Job Title: Medical Review Physician 1
Location: Bangalore, India
Employment Type: Full-Time
Experience Level: Mid-Level (2–4 Years)
Department: Pharmacovigilance / Drug Safety
Job Overview
The Medical Review Physician is responsible for performing comprehensive medical review of Individual Case Safety Reports (ICSRs) to ensure accuracy, consistency, and compliance with global regulatory requirements. The role involves applying medical and scientific expertise across therapeutic areas, guiding safety data review, mentoring case processing teams, and supporting continuous process improvements in pharmacovigilance operations.
Key Responsibilities
1. Medical Review of Safety Cases
Perform medical review of serious and non-serious ICSRs, ensuring accuracy in assessing seriousness, expectedness, causality, and narrative quality.
Review ICSRs received from multiple sources — Spontaneous, Literature, Regulatory Authorities, Solicited Reports, and Clinical Trials.
Conduct triage and prioritization of cases to determine seriousness and relatedness across multiple assigned products.
Verify accurate selection and coding of adverse events using MedDRA, ensuring proper labeling assessment and narrative completeness.
Ensure all medical review (MR) activities are completed within regulatory and service-level timelines.
2. Therapeutic and Safety Expertise
Maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic areas including Oncology, Respiratory, Immunology, Neuroscience, and Rare Diseases.
Stay informed on global pharmacovigilance guidelines and regulations such as GVP, ICH-GCP, and 21 CFR.
Support ongoing signal detection and risk assessment activities through consistent and high-quality medical evaluation of safety data.
3. Collaboration & Process Support
Provide medical guidance and expert opinion to case processing teams and quality reviewers to resolve case-level queries.
Collaborate with client therapeutic teams and internal PV functions to identify and resolve case discrepancies efficiently.
Deliver constructive feedback to case processors on identified errors and improvement areas.
Participate in process improvement and quality control initiatives, helping to enhance overall compliance and workflow efficiency.
4. Training & Mentorship
Assist in the training and mentoring of case processing associates and junior medical reviewers on both medical and regulatory aspects.
Support in the implementation of training programs on GVP concepts, disease understanding, and product knowledge.
5. Compliance & Additional Duties
Adhere to all relevant SOPs, quality standards, and client conventions in case processing and medical review.
Ensure all work meets internal and external audit and inspection readiness.
Perform ad-hoc tasks and participate in organizational projects as directed by management.
Adapt to multiple client requirements and demonstrate flexibility in managing diverse therapeutic portfolios.
Candidate Profile
Education: MBBS or MD degree from a recognized medical institution.
Experience: 2–4 years of hands-on experience in medical review of ICSRs within pharmacovigilance or drug safety.
Technical Knowledge:
In-depth understanding of GVP Modules, ICH-GCP, 21 CFR, and global safety reporting requirements.
Skilled in MedDRA coding, causality assessment, and narrative writing.
Proficient in MS Office tools (Word, Excel, PowerPoint, Outlook).
Core Competencies:
Excellent analytical and medical evaluation skills.
Strong written and verbal communication.
Team mentoring and training ability.
Detail-oriented with a commitment to quality and compliance.
Capable of multitasking and adapting to complex case portfolios.
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