Job Description

Safety Evaluation & Risk Management

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Position: SERM Physician

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Location: PAN India

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Experience: 5+ Years

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Salary: Up to 30 LPA

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Degree : B.Pharm/D.Pharm/MBBS/MD

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Industry : Life Sciences

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Key Responsibilities

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- Provide medical expertise in Pharmacovigilance activities, including benefit-risk evaluation and safety strategy.
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- Lead signal detection, signal validation, and signal evaluation using safety databases, clinical data, and scientific literature to identify emerging safety concerns.
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- Author, review, and provide medical oversight for aggregate safety reports, including:
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PSUR/PBRER , Annual Safety Reports, Regulatory safety submissions

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- Develop, review, and contribute to Risk Management Plans (RMPs), ensuring appropriate risk minimization strategies throughout the product lifecycle.
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- Evaluate safety signals and adverse event trends, recommending appropriate risk mitigation measures, labeling updates, and regulatory actions when required.
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- Provide medical review and oversight for:
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Clinical Study Protocols, Investigator Brochures (IB), Informed Consent Forms (ICF), (CSR)

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- Collaborate closely with cross-functional global teams, including Clinical Development, Regulatory Affairs, Medical Affairs, Product Scientists, and Pharmacovigilance stakeholders to support informed safety decisions.
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- Ensure inspection readiness by maintaining compliance with global Pharmacovigilance regulations, including ICH Guidelines and GVP Modules.
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Mandatory hands-on experience in:

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- Aggregate Safety Report Authoring & Review (PSUR/PBRER, Annual Reports)
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- Signal Detection & Signal Evaluation
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- Robust understanding of: Benefit-Risk Assessment, Risk Management Plans (RMP), Global Pharmacovigilance regulations, ICH Guidelines, GVP Modules
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- Regulatory safety reporting requirements
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- Excellent analytical, medical writing, stakeholder management, and

📌 SERM Physician (Bengaluru)
🏢 Latinum Hr Solutions
📍 Bengaluru