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
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