Role & responsibilities

- Receive, record, and document adverse drug reactions (ADRs) from healthcare professionals, consumers, and field staff.
- Conduct thorough investigation of reported ADRs using standard case investigation forms and assessment criteria.
- Evaluate causality, severity, and outcome of reported adverse events using standardized pharmacovigilance tools.
- Prepare and submit Serious Adverse Event (SAE) reports to DCGI and IEC/ethics committee within stipulated timelines.
- Maintain periodic safety update reports (PSUR), including preparation of development safety update reports (DSUR) as required.
- Generate Periodic Safety Update Report (PSUR) and development safety update reports (DSUR).
- Prepare safety summaries and risk assessments for regulatory submissions and clinical trial documentation.
- Maintain accurate pharmacovigilance databases and ensure proper data integrity and GCP compliance.
- Perform signal detection and trend analysis of adverse events using statistical and observational methods.
- Conduct literature review and competitor intelligence on product safety profiles
- Prepare and maintain Standard Operating Procedures (SOPs) for pharmacovigilance processes
- Coordinate with clinical teams, medical representatives, and other CFTs on safety-related inquiries
- Maintain traceability for all pharmacovigilance activities for inspection readiness.




- Attend regulatory meetings and provide safety data presentations as required

REQUIRED QUALIFICATIONS

- Bachelor's degree in Pharmacy (B.Pharm), or Post-graduate qualification (M.Pharm) in Pharmacology preferred.
- Certification in Pharmacovigilance (e.g., Diploma in Pharmacovigilance from recognized institutions).
- Valid pharmacy registration with respective State Pharmacy Council (if applicable)

EXPERIENCE REQUIREMENTS

- 2-5 years of skilled experience in pharmacovigilance, medical safety, or drug safety monitoring in pharmaceutical industry or clinical research
- Demonstrated experience with adverse event reporting systems and pharmacovigilance software/databases
- Experience in preparing regulatory submissions and safety documentation for DCGI/FDA
- Exposure to clinical trial safety monitoring and GCP compliance
- Experience with international pharmacovigilance guidelines (ICH E2A, ICH E2C, WHO guidelines) is beneficial

Preferred candidate profile

CORE COMPETENCIES & KNOWLEDGE

- Strong attention to detail and accuracy in documentation
- Excellent written and verbal communication skills in English and regional languages
- Problem-solving and analytical thinking abilities
- Team collaboration and cross-functional coordination
- Commitment to regulatory compliance and patient safety

📌 Manager - Pharmacovigilance (Chennai)
🏢 Linux Laboratories
📍 Chennai