Position: Safety Evaluation & Risk Management (SERM Physician)Location: PAN IndiaExperience: 5+ YearsSalary: Up to 25 LPAEmployment Type: Full-timeDegree : MBBS / MDIndustry : Life SciencesKey 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- Robust 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 [email protected] & [email protected]

📌 Serm Physician (Sangli)
🏢 Latinum Hr Solutions
📍 Sangli