293 Drug Safety jobs in India

Drug safety associate

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Indegene

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Job Description

permanent
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 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:You will be responsible for:Data Management:Perform duplicate search as per the requirement.Process Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, and in accordance with client specific requirements and timelines.Identify serious adverse events, and special scenario cases which includes lack of efficacy, exposure and pregnancy case, At Risk, and product quality complaint only cases.Ensure scientific rigor through accurate, complete and consistent data entry of adverse events reports from source document with emphasis on timeliness and quality.Data entry of all fields including verbatim as per Client conventions.Responsible for coding which includes adverse events, medical history, Lab data, Indications etc. using standardized terminology from a medical coding dictionary, such as Med DRA.Code products (Suspect/co-suspect, Concomitant) as per Client conventions and Regulatory requirements.Draft narratives summarizing the essential details of the case.Identify clinically relevant information missing from case report and facilities its collectionPerform labeling for Serious/Non-Serious CasesRequest for follow-up information by using relevant questionnaireManage special requests for case processing prioritization (e.g., emails from clients regarding cases that must be processed urgently upon receipt of email notification)Follow standard operating procedures (SOPs) and work instructions related to case processing. Adhere to pharmacovigilance regulations, guidelines, and internal policies to ensure compliance and data integrity. Understanding adverse event reporting requirements and compliance with data privacy regulations is important.Should be open to continuous learning, staying updated with industry changes, new reporting requirements, and emerging safety concerns.Skills:Understand the principles and concepts associated with case-handling process and overall Drug Research Process.Handling of cases in Aris G LSMV safety database ( Mandatory ) Cognitive abilities including verbal reasoning, attention to detail, and critical and analytical thinkingGood knowledge on therapy area/medical terminologyGood comprehension skillsGood communication (verbal and written), with fluency in English and interpersonal skillsYour impact: About you: Must have: Attention to detailGood comprehension skills.Good communication (verbal and written), with fluency in English and interpersonal skills.EQUAL OPPORTUNITYIndegene 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.
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Drug Safety Associate

Bengaluru, Karnataka Indegene

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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

Bengaluru, Karnataka Bitwise Solutions

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Job Description

Drug Safety Associate Job Duties

Drug safety associates responsibilities include:

- Reviewing adverse event reports, safety data sheets, and physician advisories to identify potential risks associated with a particular drug
- Conducting site visits to observe the distribution process to ensure compliance with federal regulations
- Monitoring compliance with drug licensing laws and regulations
- Ensuring the safe handling of pharmaceuticals by maintaining proper storage conditions
- Preparing reports about the status of drug inventories and other pertinent information to management
- Suggesting methods to improve workflow processes within the pharmacy department
- Administering medications to individuals according to established protocols
- Providing assistance in the investigation of medication errors or problems with drug labeling or packaging

**Salary**: ₹14,940.66 - ₹34,094.01 per month

**Benefits**:

- Internet reimbursement

Schedule:

- Day shift

Ability to commute/relocate:

- Bangalore, Karnataka: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)
This advertiser has chosen not to accept applicants from your region.

Drug Safety Associate

Mumbai, Maharashtra Ardent Research

Posted today

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Job Description

**Job description**

Attend calls from people requiring medical care/who have taken sponsor’s medication in a trial/post-marketing exposure to the drug and provide information as needed.
- Provide call handling training to the newly hired resources o Training on SOPs and Workflow instructions to the newly hired resources
- Understand the requirements of the callers and provide precise information o Provide QC support for the MICC
- Thorough understanding on use of FAQs
- Complete case entry including case narrative writing, coding from the MedDRA dictionary and WHO drug dictionary as per applicable SOPs and Client requirements.
- Manage product-specific inquiries/medical inquiries, product complaints, AEs/SAEs calls, legal complaints, call processing per SPG, SOPs and other related guidelines.
- Respond to web-based and written inquiries from Health Care Professional members and consumers concerning the safety and effective use of all products marketed in a timely manner.
- To identify and retrieve relevant data and information appropriate to answer the information requested
- Identify clinically relevant information and preparation of follow up request as needed.
- Receive, review and process Drug Safety information based on regulations and conventions
- Manage workload under the direction of Team Lead

**Salary**: ₹19,212.13 - ₹28,571.56 per month

**Benefits**:

- Health insurance
- Internet reimbursement

Schedule:

- Day shift
- Morning shift

Supplemental pay types:

- Performance bonus

**Speak with the employer**

+91
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Drug Safety Associate

Nashik, Maharashtra Fusion Market Research

Posted today

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Job Description

_**Responsibilities**_
- Collect, review, and evaluate safety data related to drugs
- Monitor adverse events and safety signals related to drugs
- Contribute to safety reviews, safety analyses, and risk management plans
- Assess and report adverse drug reactions to regulatory authorities
- Collaborate with cross-functional teams to ensure drug safety
- Participate in the development of safety databases and data management systems
- Ensure compliance with regulatory guidelines and best practices
- **Requirements**_
- Bachelor’s degree in Pharmacy, Life Sciences, or related field
- Knowledge of drug safety regulations and guidelines
- Strong analytical and problem-solving abilities
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced, deadline-driven environment
- Attention to detail and accuracy

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

Pay: ₹30,970.30 - ₹50,539.63 per month

**Benefits**:

- Health insurance
- Paid sick time
- Provident Fund

Schedule:

- Day shift
- Monday to Friday

Supplemental Pay:

- Performance bonus
- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Work Location: In person
This advertiser has chosen not to accept applicants from your region.

Medical Reviewer-Drug Safety Physician

Bengaluru, Karnataka Indegene

Posted 3 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 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.
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Medical Reviewer-Drug Safety Physician

Bengaluru, Karnataka Indegene

Posted 2 days 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.

Medical Reviewer-Drug Safety Physician

Bengaluru, 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.
 

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