Indegene is hiring for the position of Drug Safety Associate in its Pharmacovigilance team. The opportunity is suitable for healthcare and life-sciences professionals with relevant experience in drug safety, ICSR case processing, medical coding, case quality review, and Pharmacovigilance compliance.
The company is looking for professionals who can process Individual Case Safety Reports (ICSRs), identify serious adverse events and special situations, perform MedDRA and product coding, prepare case narratives, conduct quality checks, and ensure compliance with applicable Pharmacovigilance regulations and client-specific requirements.
An upcoming walk-in drive is scheduled in Pune on 19 September 2026, providing an opportunity for eligible Drug Safety and Pharmacovigilance professionals to participate in the recruitment process.
Indegene Drug Safety Associate Walk-In Details
| Job Details | Information |
|---|---|
| Company | Indegene |
| Position | Drug Safety Associate |
| Department | Pharmacovigilance / Drug Safety |
| Location | Pune, Maharashtra |
| Walk-In Date | 19 September 2026 |
| Time | 9:00 AM – 3:00 PM |
| Venue | 8th Floor, 43 EQ, Off Bhartiya Vidyapeeth School, Balewadi, Pune – 41104 |
| Contact Persons | Augustine Raj & Monish Kumar |
| Job Type | Full-time |
| Posting Start Date | 15 September 2026 |
About Indegene
Indegene is a technology-led healthcare solutions provider focused on helping healthcare organizations become future-ready. The company operates at the intersection of healthcare, technology, data, and innovation, providing opportunities for professionals to develop their careers in a global environment.
For Drug Safety professionals, the role offers exposure to Pharmacovigilance case processing, safety databases, medical coding, regulatory compliance, quality control, and global drug-safety operations.
Drug Safety Associate Job Description
As a Drug Safety Associate at Indegene, the selected professional will be responsible for processing and reviewing Individual Case Safety Reports from multiple sources while meeting applicable regulations, client requirements, timelines, quality standards, and internal procedures.
The position combines ICSR case processing and quality-control responsibilities, requiring candidates to accurately evaluate medical information, identify important safety scenarios, perform coding, prepare narratives, and validate safety data against source documents.
Key Responsibilities
ICSR Case Processing
The Drug Safety Associate will:
- Process Individual Case Safety Reports (ICSRs) received from all applicable sources.
- Process cases according to applicable Pharmacovigilance regulations.
- Follow client-specific requirements, conventions, and processing timelines.
- Perform accurate, complete, and consistent data entry from source documents.
- Enter all required case fields, including verbatim information according to client conventions.
- Ensure data quality, accuracy, completeness, and timeliness.
Serious Adverse Events & Special Scenarios
The role involves identifying and appropriately handling:
- Serious adverse events
- Lack of efficacy cases
- Exposure cases
- Pregnancy cases
- At-risk cases
- Product quality complaint-only cases
- Other special scenarios applicable to case processing
Candidates must be able to recognize clinically relevant information and understand when additional information is required.
Medical Coding
The Drug Safety Associate will perform medical coding using standardized terminology, including:
- MedDRA coding
- Adverse event coding
- Medical history coding
- Laboratory data coding
- Indication coding
- Product coding
Products may need to be coded as suspect, co-suspect, or concomitant products according to client conventions and regulatory requirements.
Case Narrative Preparation
Responsibilities include drafting accurate case narratives that summarize the essential clinical and safety information contained within the report.
The associate will also identify clinically relevant information missing from the case and facilitate collection of additional information where required.
Follow-Up & Case Management
The role includes:
- Requesting follow-up information using appropriate questionnaires.
- Managing urgent case-processing requests.
- Prioritizing cases based on client instructions.
- Responding to case-processing priorities communicated by clients.
- Supporting administrative and procedural activities associated with case processing.
Labeling & Case Assessment
The Drug Safety Associate will also be responsible for activities involving:
- Serious/non-serious case labeling
- Reportability assessment
- Valid/invalid workflow assessment
- Seriousness criteria
- Listedness assessment
- Case assessment
- Product coding confirmation
Pharmacovigilance Quality Control Responsibilities
A significant component of this position involves QC review of Individual Case Safety Reports.
The professional will:
- Review critical ICSR fields.
- Verify reportability.
- Check conformity with applicable E2B standards.
- Validate case data against source documents.
- Review medical coding.
- Review case narratives.
- Verify study information.
- Confirm the accuracy of adverse event information.
- Determine whether adverse events are correctly captured based on the patient’s clinical presentation.
- Confirm appropriate MedDRA coding.
- Verify seriousness criteria.
- Confirm or update product coding.
- Confirm or update seriousness assessment.
- Review listedness.
- Perform case assessment.
- Determine whether cases meet client-defined criteria for valid or invalid workflows.
This makes the position particularly relevant for professionals with experience in PV case processing as well as ICSR quality review/QC.
SOP & Regulatory Compliance
The selected candidate must follow applicable:
- Standard Operating Procedures (SOPs)
- Work instructions
- Pharmacovigilance regulations
- Regulatory guidelines
- Internal company policies
- Client-specific requirements
- Data integrity requirements
- Data privacy requirements
An understanding of adverse event reporting requirements and data privacy regulations is important for this role.
Training & Mentoring Responsibilities
The Drug Safety Associate may also be expected to:
- Attend Pharmacovigilance training sessions.
- Support training of other case-processing associates.
- Mentor colleagues when required.
- Assist with development of tools that improve understanding of Pharmacovigilance across the organization.
- Stay updated with emerging safety concerns and changes in industry and reporting requirements.
Skills Required
Candidates should demonstrate the following skills:
- Understanding of Pharmacovigilance case-handling processes.
- Understanding of the overall drug research process.
- Strong attention to detail.
- Critical-thinking ability.
- Analytical skills.
- Strong verbal reasoning.
- Ability to critically evaluate medical information.
- Good knowledge of medical terminology and therapy areas.
- Good understanding of disease pathology and physiology.
- Knowledge of pharmacology and therapeutics.
- Excellent written and verbal English communication.
- Strong comprehension skills.
- Training and mentoring capabilities.
- Problem-solving ability.
- Ability to identify when complex cases require additional input.
- Ability to work independently with minimal supervision.
- Computer literacy.
- Understanding of relational databases.
- Familiarity with Pharmacovigilance safety databases and compliance activities.
- Ability to streamline workflows and improve operational effectiveness.
Experience with Pharmacovigilance Safety Databases
The role requires candidates to demonstrate computer literacy, particularly in managing relational databases and working with Pharmacovigilance safety databases and compliance activities.
Experience with safety database workflows, ICSR processing, medical coding, QC, and regulatory compliance can be particularly relevant for this position.
Eligibility Criteria
Based on the supplied recruitment information, candidates should carefully review the following conditions before attending the walk-in interview:
- Candidates should be qualified healthcare professionals.
- Relevant Pharmacovigilance / Drug Safety experience is required.
- Relevant ICSR case-processing experience is important.
- Experience with safety databases and Pharmacovigilance workflows is preferred.
- Candidates should have strong medical terminology knowledge.
- Candidates should have good English communication skills.
- Candidates should be comfortable working independently and as part of a team.
- Candidates should be capable of handling routine and complex case-processing situations.
Important Walk-In Eligibility
- Only candidates currently based in Pune are eligible to attend.
- Freshers are not being considered for this recruitment drive.
- Candidates with irrelevant experience are not eligible.
- Career gaps of more than one year are not being considered.
- Immediate joiners are preferred.
- Candidates with up to 30 days’ notice period are preferred.
Key Areas for Interview Preparation
Candidates preparing for the Indegene Drug Safety Associate interview should revise:
- ICSR case processing
- Case validity assessment
- Seriousness criteria
- Reportability
- Expectedness/listedness
- MedDRA coding
- Product coding
- Medical history coding
- Laboratory data coding
- Indication coding
- Special scenarios
- Pregnancy and exposure cases
- Lack of efficacy cases
- Product quality complaints
- Case narrative writing
- Follow-up processing
- ICSR QC
- E2B standards
- SOP compliance
- Pharmacovigilance regulations
- Data privacy
- Medical terminology
- Pharmacology and therapeutics
Walk-In Interview Venue
Indegene – Drug Safety Associate Walk-In
📅 Date: 19 September 2026
⏰ Time: 9:00 AM – 3:00 PM
📍 Venue:
8th Floor, 43 EQ
Off Bhartiya Vidyapeeth School
Balewadi, Pune – 41104
👤 Contact Persons:
Augustine Raj & Monish Kumar
Documents to Carry
Candidates attending the interview should carry:
- Updated resume/CV
- Valid government-issued ID proof
Candidates should ensure that their CV clearly highlights their Pharmacovigilance, ICSR, medical coding, safety database, QC, and regulatory compliance experience.
How to Apply
📩 For Queries: medicalaffairs.jobs@indegene.com
