SERM Physician

Latinum HR Solutions · Mumbai, India

We're Hiring | SERM Physician (Safety Evaluation & Risk Management)

Are you passionate about Drug Safety, Pharmacovigilance, and Medical Risk Assessment? We are looking for an experienced SERM Physician to join our global Pharmacovigilance team and play a critical role in ensuring patient safety throughout the product lifecycle.

Eligibility Criteria

•Position: SERM Physician

• Location: PAN India

• Experience: 5+ Years

• Salary: Up to 35 LPA (Depending on Exp)

• Employment Type: Full-time

• Degree : MBBS / MD

Key Responsibilities

• Provide medical expertise in Pharmacovigilance activities, including benefit-risk evaluation and safety strategy.

• Lead signal detection, signal validation, and signal evaluation using safety databases, clinical data, and scientific literature to identify emerging safety concerns.

• Author, review, and provide medical oversight for aggregate safety reports, including:

• PSUR/PBRER

• Annual Safety Reports

• Regulatory safety submissions

• Develop, review, and contribute to Risk Management Plans (RMPs), ensuring appropriate risk minimization strategies throughout the product lifecycle.

• Evaluate safety signals and adverse event trends, recommending appropriate risk mitigation measures, labeling updates, and regulatory actions when required.

• Provide medical review and oversight for:

• Clinical Study Protocols

• Investigator Brochures (IB)

• Informed Consent Forms (ICF)

• Clinical Study Reports (CSR)

• Safety governance documentation

• Collaborate closely with cross-functional global teams, including Clinical Development, Regulatory Affairs, Medical Affairs, Product Scientists, and Pharmacovigilance stakeholders to support informed safety decisions.

• Ensure inspection readiness by maintaining compliance with global Pharmacovigilance regulations, including ICH Guidelines and GVP Modules.

• Mandatory hands-on experience in:

• Aggregate Safety Report Authoring & Review (PSUR/PBRER, Annual Reports)

• Signal Detection & Signal Evaluation

• Strong understanding of:

• Benefit-Risk Assessment

• Risk Management Plans (RMP)

• Global Pharmacovigilance regulations

• ICH Guidelines

• GVP Modules

• Regulatory safety reporting requirements

• Excellent analytical, medical writing, stakeholder management, and communication skills.

• Experience working within global cross-functional matrix organizations will be highly preferred.

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