Pharmacovigilance Physician – Medical Devices & Combination Products
Role : Medical Device Physician
Experience: 3+ Years
Location: Mumbai/Pune/Bangalore
Qualification: MBBS / MD
Budget : Upto 35 LPA
Work Mode: Hybrid
Key Responsibilities:
- Perform medical assessment and validation of Individual Case Safety Reports (ICSRs) involving combination products and medical devices.
- Review medical device complaints , including device malfunctions and usability-related issues.
- Assess cases for seriousness, causality, reportability, and device-related events .
- Ensure accurate completion of device-related fields, including device problems, malfunctions, seriousness, and causality assessments.
- Provide appropriate justification for reportable and non-reportable device-related events .
- Review line listings for marketed and investigational products, as applicable.
- Provide medical input on case-related queries from cross-functional teams.
- Contribute to Patient Safety process improvements and operational activities.
- Support peer review / medical review quality-control activities and participate in audits when required.
- Mentor and train new or less-experienced team members on medical device and combination product review processes.
- Ensure compliance with established processes, regulatory requirements, quality standards, and timelines.
Required Skills & Experience:
- MBBS / MD with clinical experience and strong knowledge of General Medicine
- Experience in Pharmacovigilance / Medical Safety / Clinical Safety
- 2–3 years of medical review experience in combination products and medical devices
- Hands-on experience with device complaint assessment
- Knowledge of reportability, seriousness, and causality assessment
- Experience with MedDRA, IMDRF, and WHODrug coding dictionaries
- Solid understanding of Pharmacovigilance regulations
- Knowledge of medical devices, including device malfunctions and usability issues
- Strong scientific, clinical, analytical, and communication skills
- Ability to independently manage responsibilities and work effectively with cross-functional teams
- Strong organizational, interpersonal, negotiation, and problem-solving skills
? Interested candidates can share their updated CV at
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📌 Pharmacovigilance Physician (Bengaluru)
🏢 Latinum Hr Solutions
📍 Bengaluru