- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. ... PVRI reports received from CSPV vendors.Responsibilities: Strategic Partner Management: Oversees Local/ Global PV service providers responsible for Call Center,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requiredExperience with safety databases and signal detection platforms requiredExperience in global PV inspection and/or audits requiredStrong knowledge of ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE)...global PV regulations and signal detection methodologies required Daiichi Sankyo,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality excellence through effective business partnerships with ... and effective business partnering to support the cross-functional implementation of Global RD/ PV QA's Strategy, Vision, and Mission.Cultivate a culture… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers responsible for Medical Assessment of ... reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor...Medical Review Team. Relationship Reports directly to Head of PV Case Management. This role involves the oversight of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health authority regulations and Novo Nordisk requirements in relation to the Pharmacovigilance ( PV ) process at NNI. This role fulfills the Quality Assurance ... driven, for the covered processes. Relationships Reports to the Director , Quality Assurance. Interfaces with multiple NNA/S Quality departments...Acts in role of Quality Assurance for NN Deviation process within the PV domain, including review… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …units in Patient Safety, NAO QA, NNI Legal, NNI Compliance, NNI Commercial, NNI Finance, Global Business Services (GBS), PV & GDP Auditor(s) as well as with ... accuracy and completeness of data collection programs and associated SDEAs in the Global Safety PV Oversight System Monitors and manages the Patient Safety… more
- Bristol Myers Squibb (Madison, NJ)
- …healthcare and strengthen the foundation of Patient Safety. **Position Summary / Objective** The Director , PV Global Process Lead, will design, optimize, ... reporting, risk management, and the PV System Master File. Partnering with Global Process Owners, the PV GPL will define and deliver strategies and… more
- Ascendis Pharma (Princeton, NJ)
- …the Global Patient Safety (GPS) organization. Under the direction of the Head, Global PV Operations, the Director , ICSR Management Team is responsible ... (GPS) leadership team. + Works closely with the Head, Global PV Operations to be aware of...PV staff as applicable. + Identify opportunities for process improvements and participate in process optimization… more
- Ascendis Pharma (Princeton, NJ)
- …their skills. The Associate Director , ICSR Management Team reports to the Director , Head, ICSR Management Team within the Global Patient Safety (GPS) ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe,...PV staff as applicable. + Identify opportunities for process improvements and participate in process optimization… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …with Gilead business needs and regulatory requirements. + Stay current with evolving global PV regulations and guidance. + Support the development of GVP ... **Knowledge & Other Preferred Requirements** + Expert knowledge of the drug development process and GVP, including global regulations (FDA, EMA, ICH) and their… more
- J&J Family of Companies (Raritan, NJ)
- …America **Job Description:** Johnson & Johnson, is recruiting for a Executive Director , Therapeutic Area Safety Head, Cardiopulmonary to be located in Raritan, NJ; ... Lead (SAS TAL) within Cardiopulmonary (CP) Therapeutic Area in Global Safety Strategy & Risk Management (GSSRM) in ...J&J IM and other GMS functions to implement needed process improvements and maximize operational efficiencies + Serve as… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to join the **Patient Safety Strategic Operations** team as an **Associate Director , Patient Safety Medical Device Safety** responsible for supporting activities to ... These activities include but are not limited to ensuring compliant global processes for vigilance/safety reporting, post-market surveillance system, trending of… more
- Ascendis Pharma (Princeton, NJ)
- …activities within the scope of Ascendis PV group. . Works closely with Head of Global Patient Safety, EU QPPV and colleagues in the US to be aware of all safety ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe,...Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis… more
- Taiho Oncology (Princeton, NJ)
- …guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are ... members (Medical monitor, Project Manager, Clinical Operations, Data Management, Biostatistics, PV , PK, Biomarkers and Medical Writing etc.), to deliver high quality… more
- Actalent (Wayne, NJ)
- …Plan for the packaging facility in collaboration with Engineering Staff, QA Director /QA Manager, and Compliance Manager. + Lead and coordinate activities for all ... abilities in development, execution, and review of IQ/OQ and PQ/ PV validation protocols. + Experience in calibration, testing, and...on Oct 31, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent… more
