Role & Responsibilities
• Manage end-to-end ICSR lifecycle, including data entry into pharmacovigilance databases
• Book and triage ICSRs, ensuring compliance with PV regulations
• Perform medical coding (MedDRA, WHO-DD) and narrative writing for safety reports
• Generate follow-up letters to reporters and ensure timely case closure
• Review scientific and medical literature to identify valid ICSRs
• Perform quality checks (QC) on safety cases to ensure data accuracy and completeness
• Assist in the preparation of aggregate safety reports (PSUR, PBRER, DSUR, if applicable)
• Support signal detection activities and ADR trend analysis
• Ensure compliance with SOPs, project guidelines, and global pharmacovigilance regulations
• Stay updated with regulatory changes impacting pharmacovigilance activities
• Coordinate with cross-functional teams and affiliates to resolve safety queries
Qualification
• B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
Experience
• 2–5 years of experience in Pharmacovigilance, particularly in ICSR processing, safety data entry, and medical coding
Skills
• Knowledge of global pharmacovigilance guidelines (ICH, GVP, FDA, EMA)
• Proficiency in MedDRA and WHO-DD coding systems
• Strong experience in narrative writing and case quality review
• Excellent written and verbal communication skills
• Ability to perform quality checks and ensure regulatory compliance
Why Join Apcer Life Sciences?
• Work with a globally recognized pharmacovigilance and regulatory services company
• Exposure to international pharmacovigilance projects and a strong focus on career development
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