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Drug Safety Physician
Job in
Oregon, Dane County, Wisconsin, 53575, USA
Listed on 2026-06-18
Listing for:
Soterius, Inc.
Full Time
position Listed on 2026-06-18
Job specializations:
-
Science
Medical Science, Healthcare Compliance
Job Description & How to Apply Below
- Acquiring comprehensive knowledge of the product portfolio and safety profiles for products across therapeutic areas.
- Perform analysis and medical assessment of the available information such as case reports and ICSRs.
- Triaging cases and determining seriousness and relatedness for assigned products.
- Perform medical review and assessment of ICSRs/safety information obtained from various sources (clinical trials/post-authorization).
- Reviewing appropriate selection of adverse events from source documents, assigning appropriate MedDRA code and drafting/reviewing case narratives.
- Determining reportability of cases obtained from various sources.
- Ensure effective functioning of assigned project in compliance with client agreements and applicable regulations and guidelines.
- Management of quality, compliance, and documentation across assigned projects.
- Have ownership of assigned projects and tasks and ensure adherence to timelines and quality.
- Manage and monitor the workload of department/function and alert the functional head/ designate in the event of concerns or issues regarding personnel management that may affect the quality and functioning of the work.
- Line management for assigned personnel.
- Continuously working with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidance.
- Train and mentor personnel, as needed.
- Identify new training and development requirements relevant to the function.
- Respond to/represent department/function during audits and inspections.
- As assigned, author and review SOPs and other documents relevant for department/ function.
- Other responsibilities as assigned by the management.
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