- Sumitomo Pharma (Sacramento, CA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Medical Director .** The Associate Medical Director will ... PVRM support for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- BeOne Medicines (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs ... pharmacovigilance and epidemiological analysis + Actively leads BeiGene safety in face-to-face regulatory meetings + Actively leads and...on the program / portfolio being led. The Executive Medical Director serves as Product Safety… more
- BeOne Medicines (San Mateo, CA)
- …periodic reporting._ _Physicians in this role are also expected to provide medical safety assessment._ _In this role, you will apply effective ... **General Description:** _The Associate Director , Safety Scientist supports assigned compounds...performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely… more
- AbbVie (Irvine, CA)
- …preclinical, clinical pharmacy, clinical development, and discovery + Works closely with Executive Medical Director to establish safety strategy for each ... strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans +… more
- Ascendis Pharma (Palo Alto, CA)
- …for process improvements and participate in process optimization initiatives. + Support Medical Safety Science team with activities related to signal detection, ... + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements...with Vendor Management, PV Study Management, QPPV Office and Medical Safety Science teams for assigned activities… more
- 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
- AbbVie (South San Francisco, CA)
- … Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product safety team ... analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians work on products...Safety Statistics Group Oncology TA Head in our Safety Statistics team. The Director will have… more
- Ascendis Pharma (Palo Alto, CA)
- …identified. . Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable ... Safety Lead reports to Head of Global Medical Safety Science. Under the direction of...Pharmacovigilance Department direction, standards, and processes for supporting safety monitoring activities. . Collaborates closely with the … more
- BeOne Medicines (San Mateo, CA)
- The Executive Medical Director will support BeOne Clinical and Medical assets within the Hematology franchise by successful development of early and late ... colleagues in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational research.… more