- Sanofi Group (Morristown, NJ)
- ** Pharmacovigilance ( PV ) Case Management Head** Location: Morristown, NJ **_About the Job_** We're seeking a vigilant and dedicated professional to fill ... the position of Pharmacovigilance Case Management Head. If...the position of Pharmacovigilance Case Management Head. If you have a...FDA, Japan PMDA and EMA + Manage oversight of PV case management activities through… more
- Kelly Services (Bridgewater, NJ)
- ** Pharmacovigilance Specialist** Kelly(R) Science & Clinical is seeking a Pharmacovigilance Specialist for our top clients in Bridgewater, NJ. If you're ... collaboration with Company's vendors and affiliates to ensure that individual case reports for pre- and post-marketed products are properly produced, exchanged,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …trials and post-marketing and ensures pertinent data has been included in the case narratives. + Assists cross-functional teams with PV and safety activities ... tenacity to overcome barriers, together. Opportunity Overview As a PV Specialist, you will have a critical role in...you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who… more
- Ascendis Pharma (Palo Alto, CA)
- …Oncology Study Management Teams (SMTs) as an active member representing PV Operations team. + Participate in the conduct of Sponsored and Investigator Initiated ... Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on...CRMs, Digital Media etc.) + Participate in relevant crisis management activities within the scope of Ascendis PV… more
- Taiho Oncology (Princeton, NJ)
- …Sr. Director, PV Medical Surveillance . At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise ... compounds, as well as regulatory guidelines as they pertain to drug safety/ pharmacovigilance . + Responsible for Individual Case Safety Report (ICSR) review.… more
- AbbVie (North Chicago, IL)
- …project prioritization and to develop/implement successful solutions by leading the Global Case Management (GCM) function, translating the business vision into ... clients. . Implements and improves a robust quality system for adverse event case management . . Establishes and oversees system for adverse event processing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to individual case safety reports. + ... Patient Safety cross-functional teams. + Communicates to highest levels of senior management key pharmacovigilance findings. + Oversees or performs medical… more
- Lundbeck (Deerfield, IL)
- …+ Excellent working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management , REMS programs. + Detailed understanding ... of assigned Lundbeck products according to the FDA and global regulatory Pharmacovigilance guidelines. The incumbent will have a strong background and experience… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …GPS on key product safety governance teams as Chair of the Safety Management Team (SMT) and a member of the cross-functional Strategic Program Team (SPT). ... to work with and influence colleagues of all organizational levels, including senior management , in a matrix environment. **This role might be for you if can:**… more
- J&J Family of Companies (Fort Washington, PA)
- …- 2407021421W **Description** Kenvue is currently recruiting for: **Associate Director, Global Case Management ** This position reports to Director, Global ... Case Management and is based at Fort Washington, PA **Who...(or other functional expertise). Provides subject matter expertise in PV and global AE regulatory reporting requirements. + Participate… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …on the cross functional Strategic Program Team (SPT) and the Chair of the Safety Management Team (SMT) for the compound. The GPS Lead leads the safety strategy and ... colleagues in a matrix environment within and external to GPS including senior management . **In this role, a typical day might include:** + This Sr. Director… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …in a matrix environment within and external to GPS including senior management . The GPS Director joins Regeneron's industry leading scientific organization, and has ... for assigned compounds and products in support of safety surveillance, signal management , communication of the safety profile as appropriate for the stage in… more
- Amgen (Washington, DC)
- …+ MD/DO or international equivalent plus 3 years relevant work + Knowledge of case management and medical review SOPs and regulatory requirements for ... vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance...activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of… more
- J&J Family of Companies (New Brunswick, NJ)
- …safety-related decisions for assets throughout their lifecycle. Supports product Safety Management Teams (SMTs) and work in close collaboration with other ... + Provide support for Health Authority interactions regarding safety and risk management , both written and verbal. + Ensure high quality safety evaluations and… more