SERM Physician

Job Description

Position: Safety Evaluation & Risk Management (SERM Physician)

Location: PAN India

Experience: 5+ Years

Salary: Up to 25 LPA

Employment Type: Full-time

Degree : MBBS / MD

Industry : Life Sciences

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
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• Annual Safety Reports
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• 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
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• Investigator Brochures (IB)
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• Informed Consent Forms (ICF)
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• Clinical Study Reports (CSR)
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• Safety governance documentation
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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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• Strong understanding of:
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• Benefit-Risk Assessment
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• Risk Management Plans (RMP)
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• Global Pharmacovigilance regulations
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• ICH Guidelines
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• GVP Modules
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• Regulatory safety reporting requirements
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• Excellent analytical, medical writing, stakeholder management, and communication skills.
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• Experience working within global cross-functional matrix organizations will be highly preferred.
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Interested candidates can share at [email protected] & [email protected]