188 Drug Safety Associates jobs in India

Detailed Job Role:

• Monitor and document drug safety data, perform adverse event reporting, assist with pharmacovigilance and risk management.

KRA (Key Responsibility Areas):

• Case assessment, adverse event documentation, timely reporting, risk communication

KPI (Key Performance Indicators):

• Event processing time, report accuracy, submission regularity, follow-up efficiency

Job description:

• Job Summary:We are seeking a meticulous Drug Safety Associate to monitor, document, and manage drug safety data while supporting pharmacovigilance and risk management activities.
• The ideal candidate will ensure timely and accurate reporting of adverse events, contributing to patient safety and regulatory compliance.Key Responsibilities:
• Monitor, collect, and document adverse event data from clinical trials or post-marketing sources
• Perform case assessments and determine seriousness, causality, and expectedness of adverse events
• Prepare and submit timely safety reports to regulatory authorities
• Assist in pharmacovigilance activities, including risk management plans and safety signal detection
• Communicate safety information to relevant stakeholders and follow up on outstanding cases
• Maintain compliance with local and international regulatory requirements (GVP, ICH-GCP)

Key Performance Indicators (KPIs):

• Timeliness of case processing and report submissions
• Accuracy and completeness of adverse event documentation
• Regularity and compliance of regulatory submissions
• Efficiency of follow-ups on safety cases

Skills & Competencies:

• Strong knowledge of pharmacovigilance guidelines and regulations (GVP, ICH, FDA, EMA)
• Attention to detail and analytical skills Effective communication and documentation skills
• Ability to manage multiple cases simultaneously
• Proficiency in safety databases (eg, Argus, ARISg) and MS Office )

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.

We are seeking a highly motivated and detail-oriented recent graduate to join our Drug Safety team as an Entry-Level Drug Safety Associate. This is an excellent opportunity to launch your career in the pharmaceutical industry and contribute to the safety surveillance of our products. You will gain practical experience in various aspects of drug safety, including adverse event processing, data entry, and safety reporting. This role is perfect for individuals with a strong interest in drug safety and a desire to learn and grow in a fast-paced environment.

Responsibilities:

• Adverse Event Case Processing:

• Receive, triage, and accurately enter adverse event reports into the drug safety database.

• Ensure timely and accurate data entry in compliance with company Standard Operating Procedures (SOPs) and regulatory guidelines.
• Assist in the follow-up of adverse event reports to obtain complete and accurate information.

• Perform quality control checks on case data to ensure accuracy and consistency.

• Data Management and Safety Reporting:

• Assist in the preparation of safety reports and data summaries.

• Maintain accurate and organized drug safety records.
• Assist in the tracking and monitoring of adverse event trends.

• Learn to identify and escalate potential safety signals.

• Regulatory Compliance:

• Develop a basic understanding of global drug safety regulations and guidelines (e.g., ICH guidelines).

• Adhere to company SOPs and regulatory requirements.

• Assist in the preparation of regulatory submissions.

• General Support:

• Assist in the maintenance of drug safety databases and systems.

• Participate in team meetings and training sessions.
• Support senior drug safety staff as needed.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree in Pharmacy, Pharmacology, Life Sciences, Nursing, or a related healthcare field.
• Strong interest in drug safety and pharmacovigilance.
• Excellent attention to detail and accuracy.
• Strong organizational and time-management skills.
• Ability to work independently and collaboratively within a team.
• Good communication and interpersonal skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Must be a recent graduate.

Preferred Qualifications (but not required):

• Basic understanding of medical terminology.
• Familiarity with drug safety databases or systems.
• Coursework related to pharmacology or drug safety.

Primary Location: India, Remote

Job ID R

Category Medical Sciences

Key Accountabilities:

The below responsibilities vary as per applicable as per the job role.

General

• Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client's guidelines, and SOPs, and Global drug safety regulations
• Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
• Assist in development of project specific safety procedures, workflows and templates.
• Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
• Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
• Delegate work as appropriate to Drug Safety Assistants
• Liaising and collaborating with the relevant function at the client's end to facilitate the delivery of high-quality work
• Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
• Mentoring new recruits in the team, if required
• Archiving the source documents and relevant emails as required
• Responds to clients/customers in a timely manner

Case processing

• Monitoring of incoming reports from various sources viz mailboxes, Eudravigilance, literature searches etc.
• Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
• Preform a check on overall medical cohesiveness and consistency of the document
• Compares and analyses data provided by the affiliate with the data available on client application
• Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
• Creates the case on the safety database and performs Data entry into safety database
• Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
• Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
• Ensures MedDRA coding in accordance with "MedDRA Term selection: Points to Consider"
• Request follow-up and perform query management, as applicable Prepares medically cohesive case narratives based upon the reported information
• Routes the case to the next workflow state as applicable in the safety database Performs quality checks/validation checks
• Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
• Case reconciliation- coordinating activities with Data Management personnel
• Line listing and tabulation generation for safety reports i.e., periodic safety reports, ad hoc safety reports etc.
• Supports compliance activities for ICSRs including late case investigation of ICSRs to various Health Authorities and Business Partners to determine the assignable cause for lateness and collection of lateness documentation including corrective actions, where applicable
• Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable

Drug Safety Reporting

• Quality control of case reports, line listings, and tabulations Develop Expedited Reporting Procedures
• Maintain local drug safety reporting requirements
• Perform registration with relevant authorities for electronic reporting on behalf of sponsor
• Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
• Submission of safety reports to investigators via SIS (Safety Information System)
• Tracking and filing of submission cases as required Unblinding of SUSARs, as required
• Collect and review metrics for measuring reporting compliance
• Work with Global PV Information Office for collection and organization of global PV requirements

Regulatory Affairs

• Compares the data received from client with the information present in database for the drug applications to be remediated; identifies and updates any missing information in the database
• Creates new applications, regulatory events, product detail set, tasks, sequences and references in database based on instructions provided by client Responsible for maintaining and tracking changes in the life cycle of a medicinal product or device such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client.
• Creation of variations in the regulatory database to track labeling, quality or administrative changes, creation of references for responses to health authority regarding PSUSA or PBRER, Referrals etc. in the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures.
• Creation of reports for publishing in order to dispatch the dossier to affiliates or agency (EMA) and generation of marketing authorization status reports from the database for co-ordination of PV activities.
• Validation the data content with the latest version of SmPC and performing the xEVMPD submissions via EMA Gateway for client's products and tracking the status of submissions and acknowledgement date.

Literature Search and review

• Formulate and maintain the search strategy/strategies in line with parameters provided by the client to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from the literature database for ad hoc literature requests, regulatory requests and DSUR requests Send the citations retrieved to the requestor in the specified format Records are reviewed, and valid cases are entered into the client database Identification and maintenance of local journals in scope for local literature search
• Performing Quality Check of the developed/updated search strategies and local journals.
• Perform periodic review of database thesauri updates and implementation of necessary changes to the search strategies in a timely manner.
• Interacting with internal or external contacts to resolve issues related
  
  to literature searches

Skills:

• Sound knowledge of drug safety and the drug development process
• Knowledge of and ability to interpret and apply global safety regulations
• Experience in data analysis and evaluation of safety data
• Good presentation skills
• Analytical and problem-solving skills
• Clear understanding of the regulatory submission process
• Proficient in database/literature searches
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Excellent organizational and prioritization skills
• Ability to work collaboratively and effectively in a team environment
• Client focused approach to work
• Ability to evaluate data and draw conclusions independently
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)

Knowledge and Experience:

• Related experience in drug safety/ pharmacovigilance is desirable
• Good knowledge of medical terminology
• Excellent communication (written & spoken English + Japanese – JLPT N2 or above).
• JLPT N2 or higher certification or equivalent
• Experience with PMDA PV activities
• Experience working with Japanese-speaking PV case processing teams

Education:

• Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.), or relevant work experience in Pharmacovigilance.
• A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.

Title: Drug Safety Associate

Bangalore, KA, IN

Job Description

Must Have

Good to have

EQUAL OPPORTUNITY

Title: Drug Safety Associate

Pune, MH, IN

Job Description

Must Have

Good to have

EQUAL OPPORTUNITY

Job Description – Pharmacovigilance Officer

Position: Pharmacovigilance Officer

Location: Daman

Experience: 4–5 years

Qualification: Bachelor’s/Master’s degree in Pharmacy, Life Sciences, or related field

Certification: Pharmacovigilance Certification (mandatory)

Job Summary

We are hiring a Pharmacovigilance Officer on behalf of our client in the pharmaceutical industry. The role involves end-to-end responsibility for adverse event reporting, signal detection, and regulatory compliance to ensure the highest standards of patient safety and drug safety monitoring.

Key Responsibilities

• Manage collection, evaluation, and reporting of Individual Case Safety Reports (ICSRs).
• Perform medical coding using MedDRA/WHO Drug Dictionary.
• Prepare and review aggregate safety reports (PSURs, PBRERs, DSURs).
• Support signal detection, risk management, and safety data analysis.
• Ensure compliance with international pharmacovigilance regulations (FDA, EMA, CDSCO, ICH).
• Assist in audits, inspections, and quality checks for PV activities.
• Collaborate with global and cross-functional teams to support regulatory submissions.

Key Requirements

• 4–5 years of proven experience in pharmacovigilance/drug safety.
• Pharmacovigilance certification (mandatory).
• Strong knowledge of PV regulations, ICH guidelines, and regulatory reporting systems.
• Hands-on experience with case processing, narrative writing, and aggregate reports.
• Excellent communication, analytical, and documentation skills.

TCS is Hiring -Clinical Safety Scientist

location - Mumbai, Noida, Bengaluru

Experience Range - 5 to 10

Preferred Educational Qualification for the role - Any life science Graduate

Job Description

Literature Review

Literature review to assess ICSR, new safety signal, for inclusion in Aggregate report, for inclusion in DSR (Drug Safety reports).

Provide MAH comments for selected literature

Review of Literature Strategy

Design and interpretation of various types of studies in medicine, levels of evidence, study power for the purpose of safety analyses.

Thesaurus used for indexing medical scientific literature, relevant for literature search strategy tailoring (both ad-hoc and systematic).

Review and interpretation of current expert therapeutic guidelines for the purpose of various safety analyses.

Review of outputs triaged by the safety scientist for scientific accuracy taking into consideration all of the above criteria

Aggregate Reports:

Authoring Safety Sections of SSSRs, DSUR, aCO & PBRER.

Authoring of RMP updates & implementation plans.

Provides methodology (in collaboration with Roche clinical safety) for data presentation and assessment in the pertinent safety sections of the aggregate report (use outside the indication scope, use in special population, medication errors, characterization of risks etc.)

Asses the new information received on important safety concerns for the medicinal product.

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy

Signal Management

Review of various types of listings for Signal Detection

Understanding of signal journey and knowledge of signal management systems and process requirements.

Perform Signal validation with a brief summary.

DSR - Complete authoring, Single case analysis & MAH comments, Drafting Overall Conclusion and Review

Tailoring strategy and methodology for signal assessment

Overall assessment of the signal based on the presented data and respective recommendation for action

Reviews the content prepared by the Safety Scientist for medical, regulatory and scientific accuracy