- Novo Nordisk Inc. (Plainsboro, NJ)
- …against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the PV Oversight function in ... in a simple and understandable manner to ie team members. Relationships Reports to head of NAO Quality PV Oversight Vendor Assessment Team and is an individual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management. This role fulfills the PV ... simple and understandable manner to ie team members. Relationships Reports to head of NAO Quality PV Oversight. Maintains positive rapport and working relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …simple and understandable manner to ie team members. Relationship Reports to head of North America Operations Quality Pharmacovigilance Oversight. Maintains ... against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the PV Oversight for NNI… more
- Bristol Myers Squibb (San Diego, CA)
- …aims to be the global leader in radiopharmaceuticals . The Executive Director, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all ... and post-marketing surveillance. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards,… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …role will be based in Princeton, NJ and will report directly to the Head Pharmacovigilance and Medical Affairs - North America **Responsibilities:** * Plan, ... to successfully complete specific project goals and objectives * Work with Head , Pharmacovigilance and Medical Affairs in providing technical support so as to… more
- Colgate-Palmolive (Piscataway, NJ)
- …Summary** Serve as the Lead point of contact for all Global Pharmacovigilance functions and processes for internal & external customers and stakeholders. Contribute ... key support functions in delivering vision, training and awareness of Global Pharmacovigilance to PV and all Colgate-Palmolive employees + Lead the operational… more
- Sanofi Group (Morristown, NJ)
- …Area (TA) objectives, safety strategy and issue escalation with the Therapeutic Area Head (TAH) and Pharmacovigilance (PV) Head + Oversee third-party ... safety providers during acquisition and development periods to ensure Sanofi safety governance processes are integrated **Internal and external safety expert** + Provide PV and risk management expertise to internal and external customers + Safety expert for… more
- Ascendis Pharma (Palo Alto, CA)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Head of ICSR Management Team reports to the Head , Global PV Operations within ... Patient Safety (GPS) organization. Under the direction of the Head , Global PV Operations, Head of ICSR...working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to. + Responsible for… more
- Astellas Pharma (Cambridge, MA)
- ** Head of Solid Tumor Clinical Development** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... role in the Oncology Development Organization. **Essential Job Responsibilities:** + The Medical Head Solid Tumor Development reports to the head of Oncology… more
- Lilly (IN)
- …Position Summary: We are seeking a dynamic and innovative individual to serve as the Head of Regulatory Legal and lead the Regulatory Legal Team (RLT) at Lilly. This ... Affairs, Manufacturing & Quality (including Environmental), Global Patient Safety or pharmacovigilance , Clinical Development and other functions and teams. The ideal… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** The Head of EGDS Innovation and Center of Excellence **Location:** Morristown, NJ , Cambridge, MA **About the job** Are you ready to shape the future ... what you thought was possible. Ready to get started? Summary of the Role **The Head of EGDS Innovation and Center of Excellence** **(CoE)** will play a crucial role… more
- AbbVie (North Chicago, IL)
- …are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety (eg, product safety team physicians, epidemiologists, ... seeking an experienced statistician to serve a Safety Statistics Group Oncology TA Head in our Safety Statistics team. The Director will have oversight of… more
- Ascendis Pharma (Palo Alto, CA)
- …for employees to grow and develop their skills. The Program Safety Lead reports to Head of Global Medical Safety Science. Under the direction of Head of GPS ... leadership role for assigned products and works closely with Head of GPS Medical Science and Head ... of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable… more
- Sanofi Group (Morristown, NJ)
- …knowledge in one or two domains (eg, Operational experience in Clinical, Pharmacovigilance , Manufacturing, Site Quality Head for a Manufacturing Site, etc.). ... May lead cross-functional teams for initiatives or projects. Serves as Deputy of Head of GMP/GDP Audit, Inspection - Pipeline, Launch Team. + **Latitude of action:**… more
- Ascendis Pharma (Palo Alto, CA)
- …and develop their skills. The Sr. Vendor Management Lead reports to the Head , Vendor Management within the Global Patient Safety (GPS) organization. Under the ... direction of the Head , Vendor Management is responsible for all Vendor Management...the assigned Vendor Management activities in Ascendis. Key Responsibilities Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs)… more
- J&J Family of Companies (Titusville, NJ)
- …overall benefit/risk. The MSO will report to the GMS Therapeutic Area Safety Head (TASH), Cardiopulmonary TA and oversee the safety and benefit/risk assessment of ... potential and known risks and changes to benefit/risk, when appropriate, to the TA Safety Head , the Head of Global Safety Strategy & Risk Management (GSSRM), the… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical ... development technology portfolio, encompassing Clinical Development, Regulatory Affairs, and Pharmacovigilance domains. This role is accountable for shaping and… more
- Ascendis Pharma (Palo Alto, CA)
- …and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team. This role involves ... CA or Princeton, NJ. TAH for assigned product and Head of US RA. Phrase it as you deem...the JD. Key Responsibilities + Collaborate with Clinical Development, Pharmacovigilance , Biometrics, Core Team Members, Product Management, and Leadership… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …ensuring alignment with Gilead business needs and regulatory requirements. + Support Head of GCP/GLP Audits to implement an Effectiveness Check strategy, in ... in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities. + Significant experience leading quality,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Description** **Objective / Purpose:** + Advance the objectives and vision of the Head of Regulatory + Ensure project management support and facilitation of the ... + Serve as a strategic thought partner to the Head of Regulatory and Head of Regulatory...in at least one of the following: clinical development, pharmacovigilance , regulatory affairs or clinical supplies + Experience in… more
