Medical Physician Specialist I – Mumbai, India
Job ID: 256102
Category: Clinical / Pharmacovigilance
Location: Mumbai, India
About the Role
We are seeking a Medical Physician Specialist I to provide medical safety expertise to Sponsors of drugs, medical devices, and combination products in the post-marketing phase. This role involves primary medical review of cases, aggregate analysis, and training of case processing teams. The ideal candidate will have a medical degree (MD, DO, or equivalent), knowledge of regulatory requirements, and clinical experience, contributing to high-quality pharmacovigilance operations.
Key Responsibilities
Perform primary medical review of individual case safety reports (ICSRs), including:
Assessment of case seriousness
Evaluation of listedness/labeling
Causality assessment
Adverse event coding and narrative review
Maintain and update daily case data and feedback in relevant trackers and tools for workflow management.
Take ownership of assigned deliverables, ensuring quality, compliance, and productivity according to SLAs and KPIs.
After a tenure of one year, provide training and guidance to case processing teams on medical aspects of case handling.
Conduct aggregate and signal analysis activities in support of safety monitoring.
Promote a culture of high customer service, compliance, and scientific excellence.
Qualifications & Experience
Education:
Bachelor’s degree in Medical Science, MD, DO, or equivalent.
Relevant clinical or pharmacovigilance experience may be considered in lieu of formal education.
Experience:
1–2 years of clinical practice experience preferred.
Knowledge of medical sciences, diagnosis, therapeutics, and drug treatments/procedures.
Understanding of regulatory requirements and ICH-GCP guidelines for clinical research and pharmacovigilance.
Skills & Competencies:
Excellent written and verbal English communication skills (ILR 3+ speaking, ILR 4+ reading/writing).
Strong attention to detail, analytical skills, and time management.
Ability to work independently or in a collaborative office or home-based environment.
Commitment to quality, compliance, and continuous improvement.
Work Environment
Office-based or remote/home-based, as assigned by the line manager.
Why Join Us
Contribute to global pharmacovigilance and medical safety operations.
Work in a dynamic, client-focused environment supporting post-marketing surveillance.
Gain exposure to international regulatory standards and best practices.
Opportunity to grow in pharmacovigilance, medical review, and clinical safety leadership roles.
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