Medical Physician Specialist II
Location: Mumbai, India
Company: Fortrea
Department: Pharmacovigilance / Drug Safety
Employment Type: Full-Time
Role Summary
The Medical Physician Specialist II is responsible for providing medical safety expertise for post-marketing surveillance of drugs, medical devices, and combination products. The role involves conducting medical review of Individual Case Safety Reports (ICSRs), assessing seriousness, causality, listedness, adverse event coding, narrative review, and supporting signal detection and aggregate safety assessments.
This position plays a critical role in ensuring high-quality pharmacovigilance deliverables while maintaining compliance with global regulatory requirements, ICH-GCP guidelines, and client expectations.
Key Responsibilities
Medical Review & Safety Assessment
Perform primary medical review of adverse event cases.
Assess:
Seriousness
Listedness/Labeling
Causality
Medical Significance
Review adverse event coding and case narratives.
Ensure medical accuracy and completeness of safety reports.
Case Processing & Pharmacovigilance
Support post-marketing safety surveillance activities.
Maintain case quality and compliance standards.
Update case data and workflow tracking tools.
Ensure timely completion of assigned deliverables.
Quality Review & Oversight
Perform secondary medical review (QC Review) after required tenure.
Conduct retrospective quality reviews (QA Review).
Identify:
Error trends
Training needs
Process improvement opportunities
Support continuous quality improvement initiatives.
Signal Detection & Aggregate Safety Review
Participate in:
Signal Detection Activities
Signal Evaluation
Benefit-Risk Assessment
Aggregate Medical Reviews
Support ongoing pharmacovigilance surveillance activities.
Training & Mentorship
Provide medical guidance to case processing teams.
Train team members on:
Medical assessment
Safety evaluation
Pharmacovigilance principles
Support capability development initiatives.
Client & Stakeholder Management
Maintain strong client relationships.
Support customer-focused service delivery.
Collaborate with cross-functional safety teams.
Participate in process improvement initiatives.
Required Qualifications
Education
One of the Following:
MBBS
MD
DO (Doctor of Osteopathic Medicine)
Equivalent Medical Degree
Experience
1–2 years Clinical Practice experience.
Up to 1 year experience in:
Pharmacovigilance
Drug Safety
Clinical Research
Experience in medical review or case processing preferred.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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