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Role & Responsibilities
Perform medical review of individual case safety reports (ICSRs) from clinical trials, literature, spontaneous sources and regulatory authorities
Ensure correct assessment of adverse events for seriousness, expectedness and listedness
Review MedDRA coding for adverse events, medical history and concomitant medications
Validate causality assessment and product role classification (suspect, concomitant, interacting)
Review case narratives for medical accuracy, clinical coherence and regulatory completeness
Draft and medically review aggregate safety reports including PSURs and PADERs
Review Risk Management Plans (RMPs) and signal management documentation
Support pharmacovigilance medical writing and regulatory submission activities
Qualification
MBBS or MD (preferably Pharmacology)
OR PharmD or M.Pharm with drug safety medical writing experience
Experience
2–4 years of experience in pharmacovigilance medical review or drug safety medical writing
Hands-on exposure to PSURs, PADERs, DSURs, RMPs and signal management
reports
Skills
Strong knowledge of pharmacovigilance regulations and safety reporting standards
Proficiency in ICSR medical review and aggregate report writing
Accurate use of MedDRA terminology
High attention to clinical detail and documentation quality
Strong written and verbal communication skills
Good organizational and time management skills
Working knowledge of MS Office tools
About the Company
MSN Group is a vertically integrated pharmaceutical company with strong capabilities across APIs, formulations and drug delivery systems. The company operates structured pharmacovigilance and regulatory compliance frameworks supporting global markets, with a strong R&D-driven focus on documentation quality, lifecycle safety management and regulatory excellence.