This position will ensure medical safety data review and evaluation in accordance with post-market and pre-market regulatory requirements. Communicates potential and known risks, when appropriate, to Management, Quality Assurance, Regulatory Affairs, and Clinical Affairs personnel. Conduct clinical trial safety and commercial safety activities.
- Provides medical safety expertise to the Quality Assurance, Regulatory Affairs, and Clinical Affairs teams and programs.
- Provides safety review to post-market complaints and pre-market clinical trial events and complete appropriate documentation.
- Performs CEC process including source documents and narratives review and handling
- Manages vendors responsible for safety services including Clinical Event Committee, Date Monitoring Committee, Imaging Service, etc.
- Provides medical input into the clinical trials documents and training materials.
- Provides training on safety matters to personnel in relevant departments.
- Collaborates with cross functional teams on activities related to managing the safety of products.
- Presents post-market and clinical safety and risk management evaluations as necessary to Senior Management Team.
- Participates in post-market and pre-market clinical safety and risk management programs.
- Provides input and review to regulatory or clinical documents as appropriate, to ensure these key safety documents are of high safety and scientific quality.
- Supports operational tasks in Medical Affairs department.
- Experience in a Medical device environment preferred.
- Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc.) and present the findings clearly in both written and oral communications.
- Experience and knowledge of Good Clinical Practices in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings and risk management plans.
- Able to plan work to meet deadlines and effectively handle multiple priorities.
- Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles also desirable.
- Ability to influence, negotiate and communicate with both internal and external customers.
- Physician with Board Certification (if US) or Medical Degree holder from a recognized Medical School (if OUS) with 4-5 years related medical clinical experience.
- Experience in clinical safety, clinical research, and vigilance.
- Demonstrated in-depth knowledge of principles of clinical trial methodology and design, medical monitoring of trials, assessment of medical device risks and benefits, and safety assessment of medical devices both on the market and in development and global safety regulations.
- Experience in a medical device environment preferred.
Equal Opportunity Employer – Disability and Veteran
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