- 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 ... Individual Case Safety Reports and other safety reports pertaining...reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership Team member and advisor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience in PV; required7 or More Years Minimum of 7 years of Drug Safety / Pharmacovigilance experience, including both investigational and marketed ... centered around rare diseases and immune disorders. Summary: Oversees Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …professionals, with inquiries, case handling issues, and process improvements related to patient safety . Relationship Reports to the Head of NNI Patient Safety , ... within Intake and Triage, Medical Review, Submissions and Compliance, Global Safety , and centralized teams (eg, Training and Documentation, Quality, Supplier and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across all phases of drug development Develop and maintain Patient Safety onboarding and on-the-job training for pharmacovigilance employees, while also ... a strategic leader for the role of GxP Patient Safety , Compliance & Vendor Oversight within our Clinical, Medical...vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical ... of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug ....depending on the program / portfolio being led. The Director , Safety Scientist provides key support as… more
- Organon & Co. (Plymouth Meeting, PA)
- …programs with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance , Chemistry, Manufacturing and Controls ... pharmaceutical or biotech industry with extensive and in-depth knowledge of non-clinical safety assessment and drug development, including a strong background in… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical ... Medical Monitoring: Provide medical oversight during clinical trials to ensure participant safety and data integrity.Review and interpret safety signals, adverse… more
- Parexel (Baton Rouge, LA)
- …of Medical Monitoring and study design/execution, preferred - Good knowledge of the drug development process including drug safety , preferred - Excellent ... of diseases. Overall responsibilities of the Associate / Medical Director are to: - Provide medical and safety...needed with the support of the designated Senior Medical Director / Global Head of TA (as appropriate) Pharmacovigilance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hemophilia, growth hormone disorders) Analytical thinking skills preferred Experience with Drug Safety database preferred Experience with MedDRA coding, ... in providing guidance, oversight and project management of assigned projects in Patient Safety . Relationship Reports directly to the Director , Patient Safety … more
- Arvinas (New Haven, CT)
- …tumors with KRAS G12D mutations. On August 8 th 2025, the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for vepdegestrant- an ... detailed knowledge of the activities and procedures involved in clinical drug development. The Clinical Scientist will collaborate with Clinical Operations,… more
- BeOne Medicines (Emeryville, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... The Senior Director , Clinical Development, Solid Tumors will support BeOne...applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority… more
- Merck & Co. (North Wales, PA)
- …Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, ... drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials ... and surveillance, we ensure the safety and efficacy of our existing and pipeline products...pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific… more
- Kelly Services (South San Francisco, CA)
- …The Director , Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory requirements for adverse ... **Kelly(R) Science & Clinical** is seeking a Medical Director of Pharmacovigilance for a fulltime,...good pharmacovigilance practices and current regulations within drug safety . + Working knowledge of validated… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. Director of Observational Research, Pharmacovigilance Epidemiology and Causal Inference ... around department strategy, prioritization, and talent and culture. Additionally, the Director will work cross-functionally with Global Patient Safety and… more
- AbbVie (Chicago, IL)
- …and CAPA investigations as necessary Qualifications + MD or equivalent + Associate Medical Director I - Drug safety experience preferred but not required ... + Associate Medical Directo r II - 1 - 2 years drug safety experience with medical assessment/clinical case review required. Additional Information Applicable… more
- AbbVie (North Chicago, IL)
- …the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation, and ... assessment. Interpreting regulations related to pharmacovigilance , supporting all patient safety activities. Responsibilities: * Understands and applies… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- AbbVie (North Chicago, IL)
- …signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on ... development, and discovery + Works closely with Executive Medical Director to establish safety strategy for each...effectively conduct safety surveillance + Responsible for safety surveillance for pharmaceutical / biological / drug… more
- AbbVie (North Chicago, IL)
- …and evaluation, risk management, etc.). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Responsibilities: * ... toxicology to effectively conduct safety surveillance. * Responsible for safety surveillance for pharmaceutical / biological / drug -device combination… more
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