- Orchard Therapeutics (Boston, MA)
- …subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company. The Head of Pharmacovigilance will be responsible for leading ... the market. + Ensures the implementation and governance of a compliant Pharmacovigilance system consistent with industry best practices that: + Enabling real-time… 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)
- …will be based in Princeton, NJ (Hybrid) 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
- 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 (Northbrook, IL)
- …packages. The VP will partner with key stakeholders in development, pharmacovigilance , clinical operations, medical affairs, and commercial strategy to drive an ... statistics. This role will report to the SVP, Global Head of QSEQ, and as a member of QSEQ...approaches in portfolio decisions. + Support clinical development, regulatory, pharmacovigilance , and medical affairs by integrating RWE into clinical… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** The Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a ... that all activities of the CoE group comply with Good Clinical and Pharmacovigilance Practices, as well as all relevant internal and external regulations and… more
- Sanofi Group (Framingham, MA)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …**About the role:** Join Takeda as a Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical safety ... and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice...you will report to the Vice President, Therapeutic Area Head of Gastrointestinal and Inflammation PSPV. You may manage/oversee… more
- Ascendis Pharma (Princeton, NJ)
- …and develop their skills. Associate Director, Global Patient Safety Medical Science reports to Head of GPS Medical Science. Under the direction of Head of GPS ... days/week and 2 days remote. Key Responsibilities + Assists Head of GPS Medical Science for drug safety and... of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable… more
- Rhythm Pharmaceuticals (Boston, MA)
- …documents spanning across the development lifecycle. This role reports to the Head of Medical Writing yet works autonomously to lead work with cross-functional ... + Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents… more
- Astellas Pharma (Northbrook, IL)
- …+ The Medical Lead GU Oncology and Emerging Areas reports to the Medical Head Solid Tumor Development and has 3 key objectives they would be expected to ... vision, mission, objectives, ways of working and plans. Thought partner for Medical Head Solid Tumor Oncology Development + Leading a team of physicians 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
- Sanofi Group (Washington, DC)
- …Department, and within the guidelines given by the Global Clinical Franchise Head , the Global Clinical Development Strategy Expert (GCDSE) is a key member ... clinical and medical scrutiny. The candidate will report to the Global Clinical Franchise Head for Pneumo & New Targets and will in principle be responsible for… 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
- Pfizer (New York, NY)
- …generation Risk Management Center of Excellence (RMCoE). + Partners with the RMCoE Head to instate and maintain processes and changes. + Champions for managing and ... determine if modifications are required + In collaboration with RMCoE Head , develops/evolves/implements best practices in risk management planning, including risk… more
- J&J Family of Companies (Horsham, PA)
- …Indicators (KPIs)/Metrics for GMS strategic business initiatives, working closely with the Head of the GMS Management Office. Ensure and measure progress against ... line reports and others. + Support and coordinate with Head of GMS Management Office on topics regarding budget,...+ A minimum of 10 years of experience in pharmacovigilance or related function (eg, Regulatory Affairs, Device Vigilance,… more
- Sanofi Group (Morristown, NJ)
- …Country Medical Roadmap (CMR) through close collaboration with the Franchise Medical Head as well as demonstrating active involvement in the annual cross-functional ... Team on Sanofi-sponsored studies, as delegated by the Franchise Medical Head **External Stakeholder Engagement (25%)** + Identify, establish, build, grow, and… more
- AbbVie (Mettawa, IL)
- …subject matter experts and advisors from cross-functional teams including pharmacovigilance , legal, regulatory, medical, office of ethics and compliance (OEC) ... standards for Care Coaches) + In close collaboration with head of function, lead the annual Patient Experience functional...operate with an international perspective at above country or Head Quarter levels from prior project work + Fluent… more