Role & Responsibilities
• Perform signal detection activities across global safety databases
• Conduct medical review and assessment of aggregate safety reports (PSUR, PBRER, DSUR)
• Perform medical evaluation of Individual Case Safety Reports (ICSRs)
• Support benefit–risk evaluation and safety decision-making
• Ensure compliance with global pharmacovigilance regulations and guidelines
• Collaborate with pharmacovigilance, regulatory, and cross-functional teams
• Maintain high standards of documentation and medical review quality
Qualification
• MBBS or MD (mandatory)
• Registered medical practitioner in India
Experience
• Minimum 1 year of experience in pharmacovigilance or drug safety
• Hands-on exposure to signal detection and aggregate reporting preferred
Skills
• Strong knowledge of signal detection methodologies
• Experience with aggregate safety reports (PSUR, PBRER, DSUR)
• Understanding of global PV guidelines (ICH, GVP)
• Good analytical and medical writing skills
• High attention to detail and compliance orientation
Availability
• Immediate joiners or candidates with up to 1 month notice period preferred
About the Company
• OrciMed Life Sciences is a growing pharmacovigilance and life sciences services organisation
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