Medical Reviewer

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

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Qualification

• MBBS or MD (preferably Pharmacology)

• OR PharmD or M.Pharm with drug safety medical writing experience

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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

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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

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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.