Senior Manager/Manager - Medical Review
Crius Life Sciences · Mumbai · onsite · Posted 63d ago
Undisclosed10–15 yrsfulltimeSourced from
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About this role
Job Overview:
Accountable for the medical review function of a large OTC/consumer healthcare pharmacovigilance program handling large volume cases per year. Reports to the Director Safety and leads the medical review team, owning the medical quality and clinical judgment applied across the case and aggregate report portfolio.
Key Responsibilities:
1. Lead and own the medical review function across the case processing and aggregate report portfolio.
2. Manage a team of drug safety physicians, ensuring consistency and quality of medical judgment.
3. Provide medical review for serious cases and line listing review for non-serious cases in line with program SOPs.
4. Own causality, seriousness, and expectedness assessment standards across the operation.
5. Provide medical input and benefit-risk evaluation for aggregate reports.
6. Serve as the senior medical point of contact for the client and respond to medical aspects of regulatory queries.
7. Support signal assessment and product safety evaluation for the consumer health portfolio.
8. Ensure the medical review function remains inspection-ready and support regulatory inspections and audits.
Key Skills - Medical review leadership | Drug safety physician expertise | Causality and benefit-risk assessment | Line listing review | Aggregate report medical input | Product safety | Consumer health and OTC | Regulatory query response | Team leadership
We are an equal opportunity employer committed to fostering a diverse, inclusive, and respectful workplace. We welcome applications from all qualified candidates and do not discriminate on the basis of race, colour, religion, gender, gender identity or expression, sexual orientation, age, disability, marital status, or any other characteristic protected by applicable law. Employment decisions are based on qualifications, skills, experience, and business needs.
Required Skills
Team leadership Causality and benefit-risk assessment line listing review Medical review leadership aggregate report medical input OTC consumer health Drug safety physician expertise product safety
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
queryAuditingpharmacovigilanceOTCInspectionDrug safetyCase ProcessingRisk AssessmentHealthcaremanagement
About Crius Life Sciences
Crius Life Sciences
201
employees
₹4.1L PA avg
Avg at Crius Life Sciences
About
Soterius is a healthcare and life sciences services company specializing in pharmacovigilance, regulatory affairs, and clinical research support. It partners with pharmaceutical and biotech firms to ensure drug safety, compliance, and efficient development processes. By combining scientific expertise with technology-driven solutions, Soterius helps organizations meet global regulatory standards and deliver safe, effective therapies to patients.
Industries
Manufacturing
Employee ratings
10 reviews
4.3/ 5
Culture
3.5
Career growth
3.0
Work-life
3.9
Employees rate it well for
Overall Company43Work-Life Balance42
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