100 Drug Safety jobs in India

Pharmacovigilance Assistant I

Chennai, Tamil Nadu ICON Plc

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Pharmacovigilance Assistant I

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
- Initiates appropriate actions to protect data privacy with regards to received unrequested personal identifiers.
- Maintains data entry for SAEs and miscellaneous tracking logs for all current projects.
- Prepares and submits courier shipments and electronic safety submissions on behalf of the project teams, including acknowledgement uploads to Safety Reporting System and maintenance of address data for safety submissions.
- Mailbox Surveillance for the safety reporting group.
- Case tracker management and support.
- Approval Letters (Approval Letter Date report, Approval Letter Task, Distribution to client as per partnership).
- Distribution of safety related documents like Clinical Trial Application (CTA), Power of Attorney (PoA) or delegation documents, and website searches as support to the safety reporting intelligence team.
- Uploads documents into the electronic Trial Master File (eTMF) and tracks the status in the Safety Tracking Tools.
- Downloads Safety Reporting Post-Marketing ICSR.
- Completes MLM Searches and GCT tracking.
- Completes EudraVigilance acknowledgement of receipt (AoR) tracking in Safety Reporting System.
- Downloads and tracks MHRA AoR.
- Obtains the Safety Reporting System cover letter.
- Safety Reporting (CA Country Portal submissions, Monitoring of mailboxes and/or Client Portal, Support for expedited and periodic reporting and Bulk report submission and reconciliation)
- Performs the Translation Management Process as assigned.
- Maintain departmental and global calendars as required.
- Completion of monthly metrics.
- Perform offsite archiving activities as required.
- Coding of invoices and submission for approval.
- Applies knowledge and adheres to company policies and procedures including corporate guidelines and best practices. Flag errors/non-conformance to established processes.
- Identifies and recognizes problems that have established precedents and limited impact. Refers non-standard questions and problems to higher levels.

Project Management Support:

- Organizes project team and client meetings including scheduling, agendas, preparation of presentations and meeting minutes.
- Organizes, reviews and manages project specific information and material following applicable company processes, (such as organizational charts, Project Management Plans, project status reports).
- Supports the Project Manager with financial tasks. Support and processes purchase orders and project invoices.
- Uploads and files all documents within allotted timeframe into the electronic Trial Master File (eTMF) or Trial Master File (TMF), including package preparation, reconciliation of the TMF and the safety tracking tools for inspection readiness, sampling and coherence QC and query resolution and follow up. Monitoring and filing of project specific mailboxes.
- Maintains training matrix, including assigning and tracking project specific trainings and tracks training compliance as applicable in the relevant system(s).
- Maintenance, coordination and access of project Enterprise Document and Content Management Systems (EDCMS) and mapped drives etc.
- Monitors project team’s approved Curriculum Vitae (CV) dates in eTMF or Project File for compliance with applicable SOP.
- Drafts the Monthly Executive Overview Report (MEOR) for Project Managers. Contacts Functional Team Leads for MEOR metrics. Enters MEOR sent dates in applicable systems.
- Updates project metrics and team members in applicable systems.
- Perform other activities as identified and requested by management.

**What ICON can offer you**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about
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Drug Safety Physician

Chennai, Tamil Nadu ICON Clinical Research

Posted 2 days ago

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Drug Safety Physician
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Drug Safety Physician to join our diverse and dynamic team. As a Drug Safety Physician at ICON, you will play a pivotal role in overseeing the medical aspects of pharmacovigilance activities, ensuring the safety of investigational drugs and contributing to the advancement of inNvative treatments and therapies.
**What you will be doing**
+ Review of coding (e.g. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious)
+ Provide support to the Drug Information & Pharmacovigilance Product Support (call) Centre and
+ the related projects, including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions
+ Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile
+ Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the line manager within ICON and discuss the agreed approach on resolution with the client
+ Provide support/training in all aspects of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post authorisation studies, spontaneous reporting and literature
+ Review and provide input to the Project Specific Procedures and participate in project related meetings
+ Communicate with the client to an extent as described in the Project Specific Procedures
+ Provide assistance in the preparation and conduct of code-break activities
+ Review, asses and provide input to Clinical Trial Protocols, Product Information, Company Core
+ Data Sheet and any other product related information as required by the client in the course of assigned project
+ Provide input and consultancy to the client in the course of generation of the Company Core
+ Data Sheet/Core Safety Information and Product Information
+ Provide pharmacovigilance consultancy to the client in terms of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorisation studies, spontaneous reporting and literature
+ Provide guidance to Medical and Safety Services staff with regards to the regulatory reporting of adverse event
+ Other responsibilities as assigned.
**Your profile**
+ Medical degree (MD or equivalent) with active medical license.
+ Board certification or equivalent experience in a relevant medical specialty (e.g., internal medicine, pharmacology).
+ Previous experience in pharmacovigilance or drug safety within the pharmaceutical or biotechNlogy industry preferred.
+ Strong clinical judgment and analytical skills, with the ability to interpret complex medical data and make informed decisions.
+ Excellent communication and collaboration skills, with the ability to work effectively within a multidisciplinary team environment.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
This advertiser has chosen not to accept applicants from your region.

Drug Safety Associate

Bengaluru, Karnataka Indegene

Posted today

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Job Description

Title: Drug Safety Associate

Date: 22 Aug 2025 Location:

Bangalore, KA, IN

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

Associate - Pharmacovigilance Officer I You will be responsible for: "Confirm validity of case by identifying minimum criteria for case creation. � Perform duplicate search to create either an initial case or a follow-up case. � Understanding the principles and concepts associated with patient safety case-handling process including regulatory requirements for reporting individual case safety reports. � Identify serious adverse events and special scenario cases which includes lack of efficacy, exposure, and pregnancy case, at risk cases, and product quality complaint only cases. � Attach the relevant source documents or any safety information/queries/follow-up information that is relevant to the case. � Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file. Responsible for coding which includes adverse event, medical history, Lab data, Indications etc using standardized terminology from a medical coding dictionary, such as MedDRA. � Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements. � Draft narratives." Your impact: About you: (Desired profile) Must have: Understand the principles and concepts associated with case-handling process and overall Drug Research Process. � Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinking. � Good knowledge on therapy area/medical terminology. � Good comprehension skills. � Good communication (verbal and written), with fluency in English and interpersonal skills. Nice to have: (Additional desired qualities) Perks: (Mention if any, otherwise ignore) EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate�s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
This advertiser has chosen not to accept applicants from your region.

Drug Safety Associate

Pune, Maharashtra Fusion Market Research

Posted today

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Job Description

**Responsibilities for this position include**:

- Identify out of scope activities in conjunction with the MSS Functional Lead
- Determining the category of information received whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines
- Reconciliation activities with all data sources providing safety information - Specialty Pharmacies, Business Partners and Internal Stakeholders to ensure compliance
- Manage and process adverse events to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines
- Accurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirements
- Perform post surveillance activities such as literature review and media monitoring
- Reconcile activities associated with Pharmacovigilance Agreements and various other sources such as product complaints, medical information inquiries and MAPs
- Responsible for keeping drug safety databases up to date
- Support the Drug Safety Team in ensuring high standards are maintained and opportunities for improvement are identified
- Act as record management coordinator for the Drug Safety Team

**Salary**: ₹15,000.00 - ₹28,000.00 per month

**Benefits**:

- Flexible schedule
- Internet reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Wagholi, Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Higher Secondary(12th Pass) (preferred)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**
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Drug Safety Associate

Amravati, Maharashtra Fusion Market Research

Posted today

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Job Description

The primary duty of a Drug Safety Associate involves the ongoing monitoring and evaluation of adverse effects and safety concerns associated with drugs and medical products following market approval.

As a Drug Safety Associate, your responsibilities will include monitoring, assessing, and reporting adverse events related to pharmaceutical products. You will collaborate with cross-functional teams, regulatory agencies, and healthcare professionals to ensure the continual evaluation of drug safety.

Key Responsibilities:

- Reporting Adverse Events
- Managing Databases
- Detecting Signals
- Evaluating and Assessing Cases
- Communication and Collaborative Efforts
- Ensuring Compliance
- Quality Assurance

Qualifications:

- Possession of a Bachelor's degree in pharmacy, life sciences, nursing, or a related field.
- Previous experience in pharmacovigilance or drug safety is desirable.
- Knowledge of pharmacovigilance regulations and guidelines.
- Strong attention to detail and analytical capabilities.
- Excellent communication and interpersonal skills.
- Ability to work effectively in a team-oriented environment.

**Job Types**: Full-time, Permanent

**Salary**: ₹223,765.03 - ₹1,231,757.67 per year

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

**Speak with the employer**

This advertiser has chosen not to accept applicants from your region.

Junior Drug safety associate

Bengaluru, Karnataka Indegene

Posted today

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Job Description

Title: Junior Drug safety associate

Date: 2 Sept 2025 Location:

Bangalore, KA, IN

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

Associate - Pharmacovigilance Officer I You will be responsible for: "Confirm validity of case by identifying minimum criteria for case creation. � Perform duplicate search to create either an initial case or a follow-up case. � Understanding the principles and concepts associated with patient safety case-handling process including regulatory requirements for reporting individual case safety reports. � Identify serious adverse events and special scenario cases which includes lack of efficacy, exposure, and pregnancy case, at risk cases, and product quality complaint only cases. � Attach the relevant source documents or any safety information/queries/follow-up information that is relevant to the case. � Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file. Responsible for coding which includes adverse event, medical history, Lab data, Indications etc using standardized terminology from a medical coding dictionary, such as MedDRA. � Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements. � Draft narratives." Your impact: About you: (Desired profile) Must have: Understand the principles and concepts associated with case-handling process and overall Drug Research Process. � Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinking. � Good knowledge on therapy area/medical terminology. � Good comprehension skills. � Good communication (verbal and written), with fluency in English and interpersonal skills. Nice to have: (Additional desired qualities) Perks: (Mention if any, otherwise ignore) EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate�s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
This advertiser has chosen not to accept applicants from your region.

Medical Reviewer-Drug Safety Physician

Bengaluru, Karnataka Indegene

Posted 15 days ago

Job Viewed

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Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below:


Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

  • MBBS and MD (mandatory)
  • Candidates without both qualifications will not be considered.


Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.


Education Requirements:

  • MBBS, MD(mandatory)
  • Medical council of India registration ( Mandatory)



Job Description:

As a Medical Reviewer – Pharmacovigilance , you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting.

Key Responsibilities:

  • Perform medical review of ICSRs for accuracy , medical relevance , and consistency with the source documents and safety database entries, in alignment with client requirements.
  • Conduct second-level triaging of non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions.
  • Review and validate:
  • Suspect product coding
  • Event selection and MedDRA coding (current version)
  • Grouping/subsuming and event ordering
  • Confirm and correct:
  • Event coding and classification
  • Ranking of events, seriousness criteria, and listedness/expectedness
  • Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
  • Assess adverse events for seriousness , listedness , and causality , ensuring all medically relevant data from source documents is accurately reflected.
  • Review and enhance narratives in compliance with client conventions.
  • Provide or verify company pharmacovigilance (PV) comments as needed.
  • Initiate appropriate follow-up queries based on the clinical context of the case.
  • Identify and escalate potential safety signals or concerns in line with client procedures.
  • Ensure completeness and medical soundness of cases before providing final medical sign-off .
  • Assess malfunctions and serious injury/death outcomes in relation to combination products.
  • Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
  • Track and document inconsistencies in data entry and provide feedback for continuous improvement.
  • Collaborate closely with cross-functional teams to maintain scientific accuracy , clarity , and regulatory compliance in all case documentation.
  • Stay updated with international pharmacovigilance regulations and follow all applicable SOPs , guidelines , and best practices .
  • Attend mandatory internal and client-specific trainings to ensure continuous compliance.

Required Skills and Competencies:

  • Strong analytical and critical thinking abilities
  • High attention to detail and scientific accuracy
  • Sound medical judgment and decision-making in line with pharmacovigilance standards
  • Proficiency in medical terminology , disease pathology, pharmacology, and therapeutics
  • Ability to analyze and interpret adverse event data
  • Strong written and verbal communication skills
  • Good comprehension and the ability to summarize complex medical data
  • Team player with effective interpersonal and collaboration skills
  • Familiarity with pharmaceutical industry practices and drug development processes (preferred)


Additional Requirements:

  • Willing to relocate to any of the listed office locations.
  • Ready to work from the office with hybrid options
  • Must possess MBBS and MD degrees (non-negotiable)



EQUAL OPPORTUNITY:

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

This advertiser has chosen not to accept applicants from your region.

Medical Reviewer-Drug Safety Physician

Bengaluru, Karnataka Indegene

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below:

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

  • MBBS and MD (mandatory)
  • Candidates without both qualifications will not be considered.

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

  • MBBS, MD(mandatory)
  • Medical council of India registration ( Mandatory)

Job Description:

As a Medical Reviewer – Pharmacovigilance, you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting.

Key Responsibilities:

  • Perform medical review of ICSRs for accuracy, medical relevance, and consistency with the source documents and safety database entries, in alignment with client requirements.
  • Conduct second-level triaging of non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions.
  • Review and validate:
  • Suspect product coding
  • Event selection and MedDRA coding (current version)
  • Grouping/subsuming and event ordering
  • Confirm and correct:
  • Event coding and classification
  • Ranking of events, seriousness criteria, and listedness/expectedness
  • Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
  • Assess adverse events for seriousness, listedness, and causality, ensuring all medically relevant data from source documents is accurately reflected.
  • Review and enhance narratives in compliance with client conventions.
  • Provide or verify company pharmacovigilance (PV) comments as needed.
  • Initiate appropriate follow-up queries based on the clinical context of the case.
  • Identify and escalate potential safety signals or concerns in line with client procedures.
  • Ensure completeness and medical soundness of cases before providing final medical sign-off.
  • Assess malfunctions and serious injury/death outcomes in relation to combination products.
  • Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
  • Track and document inconsistencies in data entry and provide feedback for continuous improvement.
  • Collaborate closely with cross-functional teams to maintain scientific accuracy, clarity, and regulatory compliance in all case documentation.
  • Stay updated with international pharmacovigilance regulations and follow all applicable SOPs, guidelines, and best practices.
  • Attend mandatory internal and client-specific trainings to ensure continuous compliance.

Required Skills and Competencies:

  • Strong analytical and critical thinking abilities
  • High attention to detail and scientific accuracy
  • Sound medical judgment and decision-making in line with pharmacovigilance standards
  • Proficiency in medical terminology, disease pathology, pharmacology, and therapeutics
  • Ability to analyze and interpret adverse event data
  • Strong written and verbal communication skills
  • Good comprehension and the ability to summarize complex medical data
  • Team player with effective interpersonal and collaboration skills
  • Familiarity with pharmaceutical industry practices and drug development processes (preferred)

Additional Requirements:

  • Willing to relocate to any of the listed office locations.
  • Ready to work from the office with hybrid options
  • Must possess MBBS and MD degrees (non-negotiable)

EQUAL OPPORTUNITY:

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

This advertiser has chosen not to accept applicants from your region.
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Medical Reviewer-Drug Safety Physician

Bangalore, Karnataka Indegene

Posted today

Job Viewed

Tap Again To Close

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below:

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

  • MBBS and MD (mandatory)
  • Candidates without both qualifications will not be considered.

Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

  • MBBS, MD(mandatory)
  • Medical council of India registration ( Mandatory)

Job Description:

As a Medical Reviewer – Pharmacovigilance , you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting.

Key Responsibilities:

  • Perform medical review of ICSRs for accuracy , medical relevance , and consistency with the source documents and safety database entries, in alignment with client requirements.
  • Conduct second-level triaging of non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions.
  • Review and validate:
  • Suspect product coding
  • Event selection and MedDRA coding (current version)
  • Grouping/subsuming and event ordering
  • Confirm and correct:
  • Event coding and classification
  • Ranking of events, seriousness criteria, and listedness/expectedness
  • Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
  • Assess adverse events for seriousness , listedness , and causality , ensuring all medically relevant data from source documents is accurately reflected.
  • Review and enhance narratives in compliance with client conventions.
  • Provide or verify company pharmacovigilance (PV) comments as needed.
  • Initiate appropriate follow-up queries based on the clinical context of the case.
  • Identify and escalate potential safety signals or concerns in line with client procedures.
  • Ensure completeness and medical soundness of cases before providing final medical sign-off .
  • Assess malfunctions and serious injury/death outcomes in relation to combination products.
  • Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
  • Track and document inconsistencies in data entry and provide feedback for continuous improvement.
  • Collaborate closely with cross-functional teams to maintain scientific accuracy , clarity , and regulatory compliance in all case documentation.
  • Stay updated with international pharmacovigilance regulations and follow all applicable SOPs , guidelines , and best practices .
  • Attend mandatory internal and client-specific trainings to ensure continuous compliance.

Required Skills and Competencies:

  • Strong analytical and critical thinking abilities
  • High attention to detail and scientific accuracy
  • Sound medical judgment and decision-making in line with pharmacovigilance standards
  • Proficiency in medical terminology , disease pathology, pharmacology, and therapeutics
  • Ability to analyze and interpret adverse event data
  • Strong written and verbal communication skills
  • Good comprehension and the ability to summarize complex medical data
  • Team player with effective interpersonal and collaboration skills
  • Familiarity with pharmaceutical industry practices and drug development processes (preferred)

Additional Requirements:

  • Willing to relocate to any of the listed office locations.
  • Ready to work from the office with hybrid options
  • Must possess MBBS and MD degrees (non-negotiable)

EQUAL OPPORTUNITY:

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

This advertiser has chosen not to accept applicants from your region.

Medical Reviewer-Drug Safety Physician

Bengaluru, Karnataka Indegene

Posted today

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Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. If this excites you, then apply below:


Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.

Education Requirements:

  • MBBS and MD (mandatory)
  • Candidates without both qualifications will not be considered.


Job Title: Medical Reviewer – Pharmacovigilance

Location:

Work from office: Bangalore, Hyderabad, Mumbai, Pune, Delhi

Willingness to relocate to one of the above locations is mandatory.


Education Requirements:

  • MBBS, MD(mandatory)
  • Medical council of India registration ( Mandatory)



Job Description:

As a Medical Reviewer – Pharmacovigilance , you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements. You will play a critical role in safeguarding patient safety through high-quality medical evaluation and regulatory reporting.

Key Responsibilities:

  • Perform medical review of ICSRs for accuracy , medical relevance , and consistency with the source documents and safety database entries, in alignment with client requirements.
  • Conduct second-level triaging of non-serious cases to identify any potential serious adverse events (SAEs), as per client-specific conventions.
  • Review and validate:
  • Suspect product coding
  • Event selection and MedDRA coding (current version)
  • Grouping/subsuming and event ordering
  • Confirm and correct:
  • Event coding and classification
  • Ranking of events, seriousness criteria, and listedness/expectedness
  • Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports.
  • Assess adverse events for seriousness , listedness , and causality , ensuring all medically relevant data from source documents is accurately reflected.
  • Review and enhance narratives in compliance with client conventions.
  • Provide or verify company pharmacovigilance (PV) comments as needed.
  • Initiate appropriate follow-up queries based on the clinical context of the case.
  • Identify and escalate potential safety signals or concerns in line with client procedures.
  • Ensure completeness and medical soundness of cases before providing final medical sign-off .
  • Assess malfunctions and serious injury/death outcomes in relation to combination products.
  • Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
  • Track and document inconsistencies in data entry and provide feedback for continuous improvement.
  • Collaborate closely with cross-functional teams to maintain scientific accuracy , clarity , and regulatory compliance in all case documentation.
  • Stay updated with international pharmacovigilance regulations and follow all applicable SOPs , guidelines , and best practices .
  • Attend mandatory internal and client-specific trainings to ensure continuous compliance.

Required Skills and Competencies:

  • Strong analytical and critical thinking abilities
  • High attention to detail and scientific accuracy
  • Sound medical judgment and decision-making in line with pharmacovigilance standards
  • Proficiency in medical terminology , disease pathology, pharmacology, and therapeutics
  • Ability to analyze and interpret adverse event data
  • Strong written and verbal communication skills
  • Good comprehension and the ability to summarize complex medical data
  • Team player with effective interpersonal and collaboration skills
  • Familiarity with pharmaceutical industry practices and drug development processes (preferred)


Additional Requirements:

  • Willing to relocate to any of the listed office locations.
  • Ready to work from the office with hybrid options
  • Must possess MBBS and MD degrees (non-negotiable)



EQUAL OPPORTUNITY:

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

This advertiser has chosen not to accept applicants from your region.
 

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