Senior Associate, Medical Review Physician
ClinChoice
Salary undisclosed
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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).
About this role
ClinChoice is seeking a Senior Associate Medical Review Physician to evaluate individual case safety reports across a range of therapeutic areas including oncology, respiratory, immunology, neuroscience, and rare diseases. You would assess serious and non-serious adverse events for seriousness, expectedness, and causality while ensuring compliance with GVP modules, ICH-GCP, 21 CFR, and other regulatory standards. The role involves reviewing cases from multiple sources—spontaneous reports, literature, regulatory submissions, solicited data, and clinical trials—and coding adverse events appropriately using MedDRA terminology. You'll also verify labeling accuracy and review case narratives to meet service level agreements and regulatory timelines.
Beyond individual case review, you would support triage decisions, identify and resolve case processing issues in coordination with client teams, and maintain current knowledge of product safety profiles across the portfolio. The position includes mentoring case processors and quality reviewers, providing expert guidance to resolve queries, and contributing to process improvement initiatives such as quality control implementation. You'll need to adapt to different client conventions and manage multiple priorities as business needs require.
This role is best suited for a physician with at least two years of hands-on medical review experience for ICSRs, strong regulatory knowledge, and demonstrated training capability. Proficiency with standard Microsoft Office applications is required. The position is based in-office in Pasig, Philippines.
How this employer is doing
solid
- H1B: Sponsors Visas
- Recently Raised Funding
- Recent Acquisition
- Sponsors Visas
In the news
ClinChoice raises $150M in series E round as CRO outlines growth plan and potential IPO, Fierce Biotech
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Pay for this role
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