- Monster (Bernards, NJ)
- …optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, ... and international regulations and applicable ICH/GCP guidelines to ensure patient safety for company's products. Provide oversight...or More Years 3 years of experience collaborating on global project teams required Experience with safety … more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Key** **Responsibilities** **Strategic Leadership** * Define and execute a comprehensive global safety and pharmacovigilance strategy aligned with ... of safety , scientific integrity, and innovation across the organization. ** Pharmacovigilance Operations** * Oversee global PV systems and processes,… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …Incumbent will drive Medical Affairs strategies and be responsible for accurate patient safety data. Provide oversight on medical information services and ... attendance via pre-meeting planning and post-meeting CI reporting + Support global Pharmacovigilance digitalization efforts to increase efficiency, quality &… more
- Sumitomo Pharma (Augusta, ME)
- …of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + Experience managing safety data, expedited ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Vice President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and ... This executive role requires a strategic business leader with experience in leading patient safety areas, proven abilities with team development, in depth… more
- United Therapeutics (Columbus, OH)
- …finding solutions and ensuring training standards are implemented and successful. This role in Global Patient Safety (GPS) will focus on enhancing and ... industry, or + 5+ years of working knowledge of Global and Local PV regulation, Quality Management principles +...years of experience in oversight or establishing training in Pharmacovigilance related areas including PV Operations, Safety … more
- AbbVie (North Chicago, IL)
- …of the Product Safety Team (PST) within the Pharmacovigilance and Patient Safety (PPS) organization's Global PV Strategy Management Office. The PPS ... level. + Excellent written and spoken English + Demonstrated working knowledge of global regulatory framework for aggregate safety reports + Solid understanding… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound(s) ... might include:** + This Director position is directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products in… more
- Lilly (Indianapolis, IN)
- …and communication skills, to contribute to an impactful research project within the Global Patient Safety (GPS) Pharmacoepidemiology (PE) group. This role ... with cross-functional teams including Statistics, Clinical Development, Regulatory Affairs, and others. ** Global Patient Safety ** GPS works to ensure that… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and ... phases in the assigned Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation… more
- Lilly (Indianapolis, IN)
- …regulatory compliance on a global scale. + Partner closely with other Global Patient Safety , Regulatory, Development and administrative functions to ... all sanctioned projects. + Drive efficiency and continuous improvement in the Global Patient Safety organization and, as appropriate, cross-functionally… more
- Ascendis Pharma (Palo Alto, CA)
- …management 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 ... Global GPS Operations in activities for monitoring patient safety and provides recommendations and strategy...identified. . Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities… more
- Amgen (Washington, DC)
- …this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a ... Join us and transform the lives of patients while transforming your career. ** Global Safety Medical Director - Hematology/Oncology** **What you will do** Let's… more
- Gilead Sciences, Inc. (Foster City, CA)
- …stakeholders, including R&D Quality Business Partners (QBPs), Inspection Management, Patient Safety , and other relevant departments. In partnership ... GVP audits, in the biopharma or related industry. + Proficiency in pharmacovigilance regulatory requirements ( Global ) is a must. + Expert-level experience… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …programming, outcomes research and epidemiology, and patient safety & pharmacovigilance ) bring their expertise to our global program teams and reimagine ... true to the best of my knowledge. **Job Description** Takeda is a global , values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver… more
- Ascendis Pharma (Palo Alto, CA)
- …ICSR Management Team reports to the Head, Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction of the Head, ... objectives. + Acts as an integral member of the Global Patient Safety (GPS) leadership...+ Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements… more
- BeOne Medicines (Emeryville, CA)
- …to marketing training materials, reviews and contributes to marketing materials **Internal Global Patient Safety Department Development** **Interfaces:** + ... programs (often multi-indication) and creates and maintains a single interpretation of global safety data for developmental and marketed products. With the… more
- Ascendis Pharma (Palo Alto, CA)
- …Management Team reports to the Director, Head, PV Vendor Management Team within the Global Patient Safety (GPS) organization. Under the direction of the ... regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. + Ability to travel up to 20% of… more
- Takeda Pharmaceuticals (Boston, MA)
- …programming, outcomes research and epidemiology, patient safety & pharmacovigilance ) bring their expertise to our global program teams and reimagine ... the best of my knowledge. **Job Description** **Objectives:** Takeda is a global , values-based, R&D-driven, top 15 biopharmaceutical leader committed to discover and… more
- AbbVie (North Chicago, IL)
- …life. This position requires strategic leadership and collaborative influence within and beyond the global patient safety organization to ensure the highest ... change. + Strong ability to lead diverse teams and influence senior leadership across global patient safety , R&D and fostering a culture of innovation… more
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