Clinical Study Physician
Location: Mumbai, Maharashtra, India
Employment Type: Permanent / Full-Time
Experience Required: 10–15 Years
Educational Qualification: MBBS or MD
Job Overview
We are seeking an experienced Clinical Study Physician to provide scientific expertise in clinical safety, literature review, and regulatory reporting. The role involves assessing safety signals, authoring clinical and aggregate safety reports, and providing Medical Affairs (MAH) input on clinical literature and guidelines.
The ideal candidate will have strong clinical knowledge, expertise in literature evaluation, and experience in pharmacovigilance or clinical research. This position ensures the accuracy and scientific rigor of safety data used for regulatory submissions and risk management activities.
Key Responsibilities
1. Literature Review & Safety Assessment
Conduct literature reviews to assess Individual Case Safety Reports (ICSRs) and emerging safety signals.
Evaluate literature for inclusion in aggregate safety reports (DSR, PBRER, DSUR).
Provide Medical Affairs (MAH) comments on literature findings and ensure scientific accuracy.
Review study design, methodology, levels of evidence, and study power for safety analyses.
Tailor literature search strategies using relevant thesauri and indexing tools.
Review current therapeutic guidelines to inform safety analyses.
2. Report Authoring & Regulatory Support
Author safety sections of SSSRs, DSURs, PBRERs, and Aggregate Clinical Overview reports (e.g., sections 5.2.4, 6.2, 9.2, 15 & 16).
Provide MAH comments for literature presented under safety sections.
Prepare Risk Management Plan (RMP) updates and implementation plans.
Ensure compliance with regulatory and pharmacovigilance standards.
3. Scientific Review & Collaboration
Review outputs triaged by safety scientists for scientific accuracy and clinical relevance.
Collaborate with pharmacovigilance, regulatory, and medical affairs teams.
Translate complex clinical findings into actionable insights for decision-making.
Required Qualifications and Experience
Education: MBBS or MD.
Experience: 10–15 years in clinical safety, pharmacovigilance, or clinical research.
Strong knowledge of literature evaluation, safety reporting, and regulatory requirements.
Experience authoring clinical and aggregate safety reports for regulatory submissions.
Ability to critically assess therapeutic guidelines, study designs, and safety data.
Key Skills & Competencies
Clinical Safety Assessment & Literature Review
Aggregate & Individual Safety Reporting (PBRER, DSUR, SSSR)
Risk Management Plan (RMP) Updates
Regulatory Compliance & Pharmacovigilance Standards
Interpretation of Clinical Guidelines & Therapeutic Evidence
Scientific Writing & Data Interpretation
Collaboration with Cross-Functional Teams
Why Join
Work at the intersection of clinical research, pharmacovigilance, and regulatory reporting.
Contribute to ensuring patient safety and regulatory compliance in clinical studies.
Collaborate with experienced cross-functional teams in a global pharmaceutical environment.
Opportunity to advance as a clinical safety and medical affairs expert with regulatory impact.
Explore more global clinical research, pharmacovigilance, and medical affairs roles at
thepharmadaily.com
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