Drug Safety Physician
About the Role
Role & Responsibilities
• Perform medical review of Individual Case Safety Reports (ICSRs)
• Conduct signal detection and interpret emerging safety trends
• Develop and review aggregate safety reports including PSURs, PBRERs and DSURs
• Support benefit–risk assessments and safety strategy discussions
• Ensure compliance with global pharmacovigilance regulations (ICH, EMA, US FDA)
• Provide medical evaluation of case narratives and literature reports
• Collaborate with cross-functional safety and quality teams
• Contribute to clinical risk management and regulatory safety activities
Qualification
• MBBS / MD (Registered Medical Practitioner in India)
Experience
• Minimum 1+ year experience in Pharmacovigilance / Drug Safety
Skills
• Signal detection & aggregate reporting
• ICSR medical review
• Global PV regulatory knowledge
• Analytical thinking & medical interpretation
• Strong written and verbal communication
About the Company
• OrciMed Life Sciences is a pharmacovigilance and drug safety organization providing global safety services, signal detection, aggregate reporting and regulatory compliance solutions to pharmaceutical companies
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