Manager - Pharmacovigilance

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 professional 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 .