Associate, Regulatory Affairs
clinchoice
Senior Associate, Medical Review Physician
clinchoice· Aggregate Reporting, Risk Management & Surveillance
About this role
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).
Frequently Asked Questions
Is the salary disclosed for the Senior Associate, Medical Review Physician position at clinchoice?
The salary for this Senior Associate, Medical Review Physician role at clinchoice is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Associate, Medical Review Physician position at clinchoice located?
This Senior Associate, Medical Review Physician role at clinchoice is based in Pasig City, Philippines. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Which team or department does the Senior Associate, Medical Review Physician at clinchoice belong to?
This Senior Associate, Medical Review Physician position is part of the Aggregate Reporting, Risk Management & Surveillance department at clinchoice. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Associate, Medical Review Physician position at clinchoice?
Click the "Apply Now" button on this page. You will be redirected to clinchoice's official application portal hosted on greenhouse where you can submit your application directly.
When was the Senior Associate, Medical Review Physician job at clinchoice posted?
This Senior Associate, Medical Review Physician position at clinchoice was posted on Mar 19, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Associate, Medical Review Physician
clinchoice
You'll be redirected to clinchoice's official application page on Greenhouse.