- Merck (Rahway, NJ)
- **Job Description** Under minimal guidance of the Executive Director/Director/Associate Director, Pharmacovigilance ( PV ) Partner Strategy & Management ( PV ... -PSM), the incumbent is responsible for PV management of all Company relationships, including business development partners, third-party vendors/suppliers, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director, Pharmacovigilance ( PV ) Operations in Cambridge, MA, where you will provide ... conducting PV operational activities for Takeda. Other PV operational activities includes regional case intake...3 years experience working with CROs, vendors, and relationship management preferred. + Must have significant PV … more
- Merck (Rahway, NJ)
- …company for your long-term goals. We support our mission by ensuring that pharmacovigilance ( PV ) activities carried out by our Research & Development Division ... regulations across the globe. We do this by ensuring compliance of the company's pharmacovigilance system with global PV requirements as well as ensuring that… more
- Merck (Rahway, NJ)
- …for your long-term goals. The Global Regulatory Affairs and Clinical Safety (GRACS) Pharmacovigilance Partner Strategy & Management ( PV -PSM) team is seeking ... and will be assigned to lead a variety of process improvement projects within PV -PSM in support of business development and vendor deals with various partners. The… more
- Ascendis Pharma (Palo Alto, CA)
- …Support 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
- GE HealthCare (NC)
- …and or vendors. This individual will support the PV infrastructure with PV operational activities such as management and support of the relationship with ... to ensure compliance/alignment with regulatory requirements and internal policies/procedures + PV Budget activities and management with a strong collaboration… more
- Ascendis Pharma (Palo Alto, CA)
- …regulatory reporting requirements and for signal detection, evaluation and risk management . + Supports Pharmacovigilance Department direction, standards, and ... to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff. + Provides pharmacovigilance expertise to Ascendis or… more
- Sumitomo Pharma (Columbus, OH)
- …position of Manager, CTSA. The CTSA Associate Manager is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) ... PV system. This role is responsible for training management , including development and maintenance of PV ...compliance issues and significant quality issues originating with the case processing vendor and License Partner. + Participates in… more
- Bristol Myers Squibb (Princeton, NJ)
- …group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate ... Safety Assessment (MSA) TA Head/Lead in developing and maintaining state-of-the-art Pharmacovigilance ( PV ) processes and procedures within BMS Drug Development… 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
- Takeda Pharmaceuticals (Boston, MA)
- …Pharmacovigilance (PSPV) team, you will report to the Director and Head, PV Document Management (PVDM). **How you will** **contribute:** + Provides leadership ... team including training, mentoring, development, and appraisals. + Assists in management of departmental budgets. + Ensures aggregate reporting processes and… more
- Merck (North Wales, PA)
- …may have continued product accountabilities including the development and execution of pharmacovigilance and risk management plans under the overall direction of ... as necessary. + Act as an expert in advanced pharmacovigilance and risk management , mentoring stakeholders outside...in performing safety surveillance activities and developing and evaluating PV activities, Risk Management Plans (RMP) and… more
- Novo Nordisk (Plainsboro, NJ)
- …minimum of 4 years' experience in clinical practice, pharmacy practice or within Pharmacovigilance ; experience in Pharmacovigilance case processing and or ... and Oversees Patient Safety (PS) employees' onboarding and on-the-job training for pharmacovigilance as well as Safety training conducted for internal and external… more
- BeiGene (Emeryville, CA)
- …+ Leads GPS product co-ordination, chairs product group meetings across GPS ** Pharmacovigilance :** + Leads and manages safety PV processes for BeiGene ... including both BeiGene and competitor products + Identifies and actively leads management of safety concerns for developmental and approved BeiGene products +… more
- Merck (North Wales, PA)
- …data integration, interactive voice response system (IVRS) services, ePRO services, pharmacovigilance case processing, data standards and platform governance. ... **Job Description** The Associate Vice President, Global Data Management & Standards (GDMS) is responsible for ensuring...and associated technical architecture; ePRO and IVRS functionalities and PV case processing activities. + Sets vision… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …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