- Ascendis Pharma (Palo Alto, CA)
- …File (PSMF) + Work collaboratively with ICSR Management, Clinical Trial, QPPV office and Medical Safety Science team for assigned activities + Is responsible for ... developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled,...desired. + Minimum of 8 years recent experience in Pharmacovigilance + Expert knowledge of FDA safety … more
- Actalent (Frederick, MD)
- Description Quality Assurance Director with extensive experience in biopharmaceutical quality assurance and management of quality programs for clinical cell therapy ... motivated professional who can oversee Quality Assurance clinical operations. The Associate Director of QA will oversee quality for GCP, GLP, and PV operations,,… more
- AbbVie (North Chicago, IL)
- …for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, risk management plans, periodic ... and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: *… more
- ThermoFisher Scientific (Wilmington, NC)
- …management and oversight of all contracted services. **Discover Impactful Work:** The Associate/ Medical Director provides medical oversight of clinical ... and/or fellowship), along with patient treatment experience (comparable to 2 years) **For Medical Director Level:** + MD or equivalent required. Active … more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. **Global Safety Medical Director - Hematology/Oncology** **What you will do** ... will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global … more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. **Global Safety Medical Director ** **What you will do** Let's do this. ... of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You… more
- ThermoFisher Scientific (Greenville, NC)
- …(comparable to 1-2 years) in the industry; Or + Direct experience in safety / Pharmacovigilance medical monitoring (comparable to 2 years). _In some ... safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... empower you to shine? Join us as a PV Risk Management Scientist/Associate Director . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Global Patient Safety (GPS) Lead role ( Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) ... and recommended risk management and minimization activities. + Ability to utilize GPS safety database for purposes of medical case review and simple queries.… more
- IQVIA (Durham, NC)
- **J** **ob Overview** The Associate Medical Director / Medical Director will provide medical , clinical and scientific advisory expertise to all IQVIA ... issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. + Performs medical review of the… more