Role Overview
Responsible for the medical review of adverse event cases within a large-volume OTC/consumer healthcare pharmacovigilance program. Provides clinical judgment across case processing and aggregate report activities.
Qualifications and Experience
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1 to 2 years of experience in pharmacovigilance, drug safety, or clinical safety.
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MBBS, MD in Pharmacology.
Key Responsibilities
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Perform medical review of ICSRs, including causality, seriousness, and expectedness assessment.
- Conduct line listing review for non-serious cases in line with program SOPs.
- Provide benefit-risk evaluation and medical input.
- Provide medical input to aggregate reports.
- Support responses to medical aspects of regulatory queries.
- Support product safety and consumer health safety assessments.
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Ensure medical review activities meet quality and compliance standards.
- Escalate safety concerns and complex cases appropriately.
Key Skills
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Medical review and clinical assessment of ICSRs.
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ICSR causality, seriousness, and expectedness assessment.
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Line listing and product safety review.
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Benefit-risk assessment and aggregate report medical input.
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Regulatory query and safety assessment experience.
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Strong clinical judgment, analytical skills, attention to detail, and communication skills.
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System and Domain Exposure
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Pharmacovigilance safety databases such as Argus, LSMV, or equivalent.
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ICSR processing and medical review workflows.
