- Ascendis Pharma (Palo Alto, CA)
- …. Assists Head of GPS Medical Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations ... for signal detection, evaluation and risk management. . Supports Pharmacovigilance Department direction, standards, and processes for supporting safety monitoring… more
- Astrix Technology (Monmouth County, NJ)
- …across various industries. We're seeking talented Medical Writers with experience in pharmacovigilance to join us! Our partners range from emerging biotech firms to ... on-site throughout the country! **Responsibilities:** + Prepare and review pharmacovigilance documents including: + Periodic Safety Update Reports (PSURs/PBRERs) +… more
- Sumitomo Pharma (Madison, WI)
- …a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to ... ongoing clinical trials. + Serve as a subject matter expert in Pharmacovigilance , including operations and medical, within the assigned program. + Support… more
- IQVIA (Durham, NC)
- …+ Assist with business partner and other query management. + Represent Pharmacovigilance on project teams. + Assist with CAPA/audit or inspection finding ... of data to support quality and compliance processes. + Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial… 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 ... of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice President, Therapeutic Area… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …North America Medical Affairs team. This is a critical role within our Pharmacovigilance and Medical Affairs team. The incumbent will be directly responsible for all ... be based in Princeton, NJ and will report directly to the Head Pharmacovigilance and Medical Affairs - North America **Responsibilities:** * Plan, organize, and… more
- Taiho Oncology (Princeton, NJ)
- …compounds, as well as regulatory guidelines as they pertain to drug safety/ pharmacovigilance . + Responsible for Individual Case Safety Report (ICSR) review. Ensures ... boundary stakeholders including TPC, PV Vendors, and Taiho Partners on all pharmacovigilance related issues. + Responsible for the maintenance and updating of… more
- Bristol Myers Squibb (Princeton, NJ)
- …The Safety Evidence and Sciences team is responsible for pharmacovigilance and pharmacoepidemiology deliverables such as signal detection, aggregate reporting, ... across numerous disciplines across all therapeutic areas + Expert knowledge of pharmacovigilance as well as emerging trends/directions in pharmacovigilance +… more
- BeOne Medicines (San Mateo, CA)
- …to integrated Benefit/Risk assessments **Promote and Advance the Field of Pharmacovigilance ** + Contribute to effective execution, communication and influence with ... training to support team development + Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are medium in complexity + Adhere… more
- United Therapeutics (Research Triangle Park, NC)
- …an option. **Who You Are** Do you have a deep understanding of pharmacovigilance (PV) regulations globally and their operational implications for a wide range of ... This role is responsible for management of Global Product Safety & Pharmacovigilance business alliance activities and contribution to AA&C projects and initiatives.… more
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