- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. **Director Global Safety ** **What you will do and what we expect of you** Let's do this. ... and review of aggregate reports; Provide oversight to staff with regards to safety in clinical trials including review of SAEs/AEs; Review and provide input and… more
- Ascendis Pharma (Palo Alto, CA)
- … experience is highly desired. + Minimum of 8 years recent experience in Pharmacovigilance + Expert knowledge of FDA safety regulations, ICH Guidelines, and ... to the Director, Head, PV Vendor Management Team within the Global Patient Safety (GPS) organization. Under the direction of the Head, PV Vendor Management Team… more
- Actalent (Frederick, MD)
- …Operations and CRO teams. * Supports the implementation and management of the Pharmacovigilance (PV) Quality Management System (QMS) and PV System for clinical and ... commercial operations, partnering with Patient Safety . * Contributes to QA audit planning and performs...* Ensures ongoing qualification of GCP, GLP, and Good Pharmacovigilance Practice (GVP) vendors and systems. * Prepares and… more
- Sanofi Group (Cambridge, MA)
- …and pharmacovigilance agreements **_Impact:_** + Ongoing assessment of the safety status of the product + Review, preparation, contribution and/or approval of ... **Job Title:** Global Safety Officer, Rare Diseases **Location:** Morristown, NJ Cambridge,...For MD, minimum 3 years' total experience in international pharmacovigilance , or equivalent relevant industry experience (eg clinical development)… more
- Sanofi Group (Morristown, NJ)
- …and pharmacovigilance agreements **Impact:** + Ongoing assessment of the safety status of the product + Review, preparation, contribution and/or approval of ... **Job Title:** Global Safety Officer, I&I **Location:** Morristown, NJ Cambridge, MA...For MD, minimum 3 years' total experience in international pharmacovigilance , or equivalent relevant industry experience (eg clinical development)… more
- Lilly (Indianapolis, IN)
- …with the development, management, execution, and oversight of all aspects of the safety program for one (or more) asset(s) throughout the product(s') life cycle. ... partnership with the integrated development or product team to deliver on these safety commitments while demonstrating GPS expertise and leadership. The CRP is the… more
- AbbVie (North Chicago, IL)
- … pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate reports. 4. Apply current regulatory ... pipeline and considered for future opportunities. Medical Directors within the Patient Safety , Epidemiology and Quality team are responsible for the following: 1.… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Global Safety Medical Director - Hematology/Oncology** **What you will do** Let's do this. ... 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing ... phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation… more