Medical Physician Specialist I – Mumbai, India
Job ID: 256105
Category: Clinical / Pharmacovigilance
Location: Mumbai, India
About the Role
We are seeking a Medical Physician Specialist I to provide medical safety expertise for post-marketing surveillance of drugs, medical devices, and combination products. The role involves primary case review, signal analysis, and team support, ensuring compliance with global regulatory standards and internal quality requirements. This position offers an opportunity to contribute to high-quality pharmacovigilance operations and collaborate with a dynamic clinical safety team.
Key Responsibilities
Conduct primary medical review of individual case safety reports (ICSRs), including:
Assessing case seriousness and listedness/labeling
Causality determination
Adverse event coding and narrative review
Maintain and update case data, feedback, and tracking tools for effective workflow management.
Take full ownership of assigned deliverables, ensuring compliance with quality standards, SLAs, and KPIs.
Provide training and guidance to case processing teams on medical aspects after one year of tenure.
Perform aggregate analysis and signal detection to support safety monitoring.
Promote a culture of high customer service, quality, and compliance.
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:
Working knowledge of medical sciences, therapeutics, and drug treatments/procedures.
Understanding of regulatory requirements and ICH-GCP guidelines.
1–2 years of clinical practice experience is preferred.
Skills & Competencies:
Fluent in English (ILR 3+ speaking; ILR 4+ reading/writing).
Strong analytical, organizational, and time-management skills.
Ability to work independently or collaboratively in office or home-based settings.
Commitment to quality, compliance, and scientific excellence.
Work Environment
Flexible working arrangement: office-based or home-based, as directed by the line manager.
Why Join
Be part of a global pharmacovigilance team ensuring patient safety.
Gain exposure to international regulatory standards and best practices.
Develop skills in clinical case review, signal detection, and post-marketing safety operations.
Opportunity to advance into leadership roles in pharmacovigilance and clinical safety.
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