20 Sep
|
Golden Opportunities
|
Mumbai
20 Sep
Golden Opportunities
Mumbai
Job Details Job Title: SERM Physician / Scientist Job Location: PAN INDIA - Mumbai, Pune, Bangalore, Noida
Work Model: Work from Office / Hybrid
Candidate Expectations Total and Relevant Experience – 3 Years to 7 Years
Candidate Location - Anywhere
Skills – signal detection, evaluation, and risk assessment
Candidate Industry (Pharma)
Diversity – No
Education and Certification Qualification: (MBBS/MD) / Life Science Graduate
Specific Remarks: Distance education not accepted.
Certification : MCI added advantage
Detailed
- Perform signal detection, evaluation, and risk assessment for assigned products
- Deliver fit‑for‑purpose safety evaluations with explicit 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
- 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)
Key Skills signal detection, evaluation, and risk assessment Other Specific Remarks Additional Requirements: Proper documents for entire career and PF Form 16 Mandatory
📌 SERM Physician / Scientist - Sr Associate - GO/JC/4576/2026 (Mumbai)
🏢 Golden Opportunities
📍 Mumbai