• Ensure compliance with global pharmacovigilance regulations (EMA, EU GVP, ICH E2A/E2B, FDA, local guidelines)
• Maintain and update pharmacovigilance documentation including SOPs and PV Master File (PSMF)
• Assist during regulatory inspections, audits, and CAPA implementation
• Support preparation, review, and submission of safety documents:
ICSRs, PSURs / PBRERs, DSURs, Risk Management Plans (RMPs)
• Submit safety reports to EudraVigilance and other global safety databases
• Perform literature screening and safety data evaluation
• Assist in signal detection, risk minimization activities, and safety review meetings
• Support preparation of SmPC, PIL, and package leaflets
• Code and review adverse events using MedDRA and WHO-DD
• Maintain accurate safety databases, trackers, and compliance logs
• Complete mandatory PV trainings and stay updated with evolving regulations
• B.Pharm
Experience
• 0–1 year of experience in Pharmacovigilance
• Freshers with PV training are eligible
• Basic understanding of pharmacovigilance regulations (EMA, EU GVP, ICH, FDA)
• Knowledge of ICSR processing and safety reporting
• Familiarity with MedDRA and WHO-DD coding
• Strong attention to detail and documentation accuracy
• Good written and verbal communication skills
• Compliance-oriented and proactive learning mindset
Lincoln Pharmaceuticals is a well-established Indian pharmaceutical company with a strong presence in domestic and international markets. The company is committed to quality, patient safety, and regulatory excellence, offering strong career growth opportunities in pharmacovigilance, regulatory affairs, and drug safety operations.
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