Medical Reviewer - Pharmacovigilance

Role & Responsibilities
• Conduct medical review and approval of selected scientific and literature articles
• Review Individual Case Safety Reports (ICSRs) in the safety database
• Perform medical labeling, causality assessment, and seriousness evaluation
• Follow up with reporters to obtain missing or additional safety information
• Review aggregate safety reports, including Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs)
• Provide medical and scientific conclusions for benefit–risk assessments
• Review and support Risk Management Plans (RMPs)
• Contribute to signal detection and signal management activities
• Ensure compliance with global pharmacovigilance regulations

Qualification
• MBBS or MD in Pharmacology

Experience
• 0–1 year of experience in pharmacovigilance or drug safety

Skills
• Strong understanding of ICSR processing and safety databases
• Knowledge of global PV regulations (ICH, GVP, FDA, EMA) is an advantage
• Prior experience in a regulated pharmaceutical company is a plus

About the Company
• Emcure Pharmaceuticals is a leading Indian pharmaceutical company, offering expertise in pharmacovigilance and drug safety operations globally.