- Lilly (Indianapolis, IN)
- …life better for people around the world. The purpose of the Associate Director - Safety Data Scientist is to manage and analyze complex Global Patient Safety ... understand data trends, assess business issues, and drive analytic solutions. The Safety Data Scientist Associate Director / Director will work with stakeholders to… more
- Amgen (Washington, DC)
- …of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. You ... the lives of patients while transforming your career. **Global Safety Medical Director** **What you will do** Let's do...In this vital role you will serve as the safety expert of the assigned product(s) within the Rare… 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) ... strategic program team (SPT) for the compound. The GPS Lead leads the safety strategy and ensures the optimal support from within GPS and works collaboratively… more
- Ascendis Pharma (Palo Alto, CA)
- …experience is highly desired. + Minimum of 4 years recent experience in Pharmacovigilance + Working knowledge of validated Drug Safety Databases (Argus ... Management Lead reports to the Head, ICSR Management within the Global Patient Safety (GPS) organization. Under the direction of the Head, ICSR Management, is… more
- Orchard Therapeutics (Boston, MA)
- …selection including laboratory endpoints, study execution, medical monitoring, safety monitoring, study report development/medical writing, etc. . Accountable ... with Clinical Operations, Data Management, Biostatistics, Regulatory, Medical Affairs, Pharmacovigilance and other teams supporting clinical development . Actively… more
- IQVIA (Durham, NC)
- …including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. + Performs medical review of the protocol, ... review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department. + May provide medical support for the Analysis of Similar… more
- Sanofi Group (Morristown, NJ)
- …in close collaboration with other functions (eg pharmacovigilance , pharmacoepidemiology, medical, regulatory, statistician, clinical operations, affiliates) ... or ad hoc need (eg product alert, regulatory authority request, emerging safety issue) + Advise on collection and integration of patients' perspective into… more
- AbbVie (North Chicago, IL)
- …Description Purpose: Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution ... to assure accurate maintenance and reporting of the Product Safety Master File (PSMF) globally. . Leadership of PV...- 7 years of experience in Quality Assurance and/or Pharmacovigilance An equivalent combination of education and experience may… more
- Takeda Pharmaceuticals (Boston, MA)
- …Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to the ... CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key… more
- Lilly (Indianapolis, IN)
- …people around the world. **Purpose:** The purpose of the Senior Director - GPS Safety Data Sciences role is to provide strategic and personnel leadership for the GPS ... needs, access expertise and resources, and share/leverage learnings. Leadership of GPS Safety Data Sciences Team + Manage operating priorities and resources of Team.… more