Senior Associate, Medical Review Physician
Compensation
Pay not listed
The week · per this posting · weekdays assumed
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Job Description
Primary Responsibilities
Awareness and understanding of relevant GVP modules.
Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials.
Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc.
Support triage of cases and determine seriousness and relatedness across products as assigned.
Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative.
Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas.
Involve in process improvement activities such as implementation of quality control process.
Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries.
Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
- Maintain PV expertise and understanding of international safety regulations and guidelines.
- Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines.
- Provide timely feedback to case processors on the errors/ discrepancies noted.
- Assist in training/mentoring of other case processing/medical review personnel as necessitated.
- Adapt to different client case processing conventions and multi-task as per business needs.
- Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement.
- Participate in organizational activities to meet objectives suitable for the role/area of expertise.
Candidate Profile
Medical Physician with at least 2 years of experience as Medical Reviewer for ICSRs.
Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements.
Training and mentoring skills (GVP concepts & medical aspects such as disease condition, product portfolio etc).
Must have hands-on experience with MS Office applications (Outlook, Excel, Word, Power Point etc).
Key Responsibilities
The role involves performing medical review of serious and non-serious Individual Case Safety Reports (ICSRs), focusing on accuracy in seriousness, expectedness, and causality while adhering to quality and compliance standards. Responsibilities also include providing medical guidance to data entry staff, resolving case issues, and maintaining expertise in product portfolios and international safety regulations.
Requirements
Candidates must be Medical Physicians with a minimum of two years of experience specifically as a Medical Reviewer for ICSRs, possessing thorough knowledge of ICH-GCP, relevant GVP modules, and 21 CFR guidelines. Essential skills include training/mentoring capabilities and proficiency with MS Office applications.
Qualifications
- Experience
- 2+ years of experience
Key Skills
Work-Life Balance Analysis
WeekdayDoc's proprietary algorithm rates Senior Associate, Medical Review Physician at Clin Choice a 6.6 out of 10 for work-life balance — classified as good. This places the position in the Above average in Physician roles — ranked against 21,897 active Physician roles listings on WeekdayDoc. Contributing factors include remote work flexibility.
Pharmacovigilance — Physician Career Context
Physician pay on WeekdayDoc is up 1.7% vs. the prior quarter (through Sep 2026).
Work-life snapshot
Listing-based score, 0–10, across 21,897 comparable listings. Shaded area = the share scoring below this one.
- Remote