Latinum HR Solutions
Website:
latinumhr.com
Job details:
Hiring : Safety Evaluation & Risk Management
Position: SERM Physician
Location: PAN India
Experience: 4+ Years
Salary: Up to 25 LPA
Employment Type: Full-time
Degree : MBBS / MD
Industry : Life Sciences
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.
📩 Interested candidates can share at gaurangna@latinumhr.com & jobs@ats.latinumhr.com
Click on Apply to know more.
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