Safety Physician

Job description

**TCS is hiring for SERM Scientist and SERM Physician role** **Job Location Mumbai - Pune | Bangalore | Hyderabad | Chennai | Indore | Kolkata | Noida** **Role Summary:** Provides scientific expertise in **Safety Evaluation and Risk Management (SERM)** across **clinical development and post‑marketing** products, ensuring robust safety assessment, signal detection, and regulatory compliance. **Key Responsibilities:** - Perform **signal detection, evaluation, and risk assessment** for assigned products - Author and review **aggregate safety reports** (PSUR/PBRER, DSUR), **RMPs** , and safety documentation - Deliver **fit‑for‑purpose safety evaluations** with clear conclusions for internal and regulatory stakeholders - Contribute to **protocols, program documents, and safety governance activities** - Identify, assess, and **escalate safety signals/issues** with recommended risk mitigation strategies - Support **health authority responses** , audits, and inspection readiness activities - Drive **process improvements** and ensure compliance with **ICH, GVP, and global PV regulations** - Collaborate within **cross‑functional matrix teams** and manage multiple deliverables with quality and timelines **Qualifications & Experience:** - Degree in **Life Sciences / Pharmacy / Biomedical Sciences** (Advanced degree preferred) - **Mandatory 3-5 Experience in Author and review** aggregate safety reports & Signal Evaluation - Strong knowledge of **ICH guidelines, GVP modules, CIOMS, and regulatory requirements** - Experience in **global matrix environments** with effective stakeholder communication **SERM Physician – Job Description (Short version)** **Role Summary:** Provides Medical Safety Evaluation and Risk Management (SERM), supporting benefit–risk assessment, signal management, and regulatory safety strategy across clinical and post‑marketing products. **Key Responsibilities:** - Provide Medical inputs on pharmacovigilance and risk management planning; **contribute to benefit–risk assessments** and Risk Management Plans (RMPs) - Drive **signal detection, evaluation, and labeling recommendations** using safety databases and literature - Author and **review aggregate safety reports (PSUR/PBRER, Annual Reports)** and regulatory submissions - Provide **medical oversight for protocols, investigator brochures** , informed consents, study reports, and safety governance forums - Evaluate and escalate safety signals/issues; recommend risk mitigation strategies and labeling updates - Collaborate with cross‑functional teams (Clinical, Regulatory, Product Scientists) for safety decision‑making - Ensure inspection readiness, audit compliance, and adherence to global PV regulations (ICH, GVP) **Qualifications & Experience:** - **MBBS / MD with Mandatory 3-5 Experience in Author and review aggregate** safety reports & Signal Evaluation - Expertise in signal management, aggregate report authoring, and benefit–risk evaluation - Strong knowledge of ICH guidelines, GVP modules, and global regulatory requirements Regards Manisha Singh (TCS -HR)