Loading Jobslly...
Role & Responsibilities
• Perform medical review and clinical assessment of ICSRs in safety databases
• Verify adverse event selection, seriousness, MedDRA coding, causality, labeling, narratives and company clinical comments
• Handle medical queries, literature screening and safety database follow-ups
• Ensure compliance with ICH, EMA, GVP and GCP guidelines
• Mentor and train PV associates on safety conventions and event capturing
• Support literature surveillance, signal detection and risk management activities
• Review and prepare PSURs, PBRERs and Risk Management Plans (RMPs)
• Participate in audits, inspections and global pharmacovigilance collaboration
Qualifications & Experience
• MBBS (PG degree preferred)
• Minimum 3 years of Pharmacovigilance / Drug Safety experience
Skills
• Strong knowledge of global PV regulations (ICH, EMA, GVP, GCP)
• Excellent communication and documentation skills
• Ability to manage complex safety cases and work in regulated environments
• Experience with safety databases and literature surveillance
About the Company
• Cencora is a global healthcare services organization dedicated to creating healthier futures worldwide.
• The company supports pharmaceutical and life sciences organizations with end-to-end drug safety, regulatory, and clinical solutions.