Role & Responsibilities
• Perform initial assessment and medical review of ICSRs in safety databases
• Review seriousness, causality, labeling, narratives, MedDRA coding and medical history
• Verify suspect drug, concomitant medications and laboratory data
• Respond to case owner queries and document medical review comments
• Identify and escalate complex case issues to team leads or line managers
• Determine follow-up requirements and ensure proper documentation
• Train and mentor PV associates on safety conventions and event capturing
• Maintain current knowledge of product safety profiles across therapeutic areas
Qualification
• MBBS / MD (PG degree preferred)
Experience
• Minimum 8 years of experience in Pharmacovigilance / Drug Safety
Skills
• Strong knowledge of ICSR medical review
• Good understanding of MedDRA coding and global PV regulations
• Excellent communication and documentation skills
• Strong organizational and mentoring abilities
• Ability to work under pressure and meet timelines
About the Company
• Cencora is a global healthcare solutions organization delivering regulatory, pharmacovigilance and medical safety services through its affiliate PharmaLex India Private Limited, supporting safer medicines and improved patient outcomes worldwide
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