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