- Takeda Pharmaceuticals (Boston, MA)
- …+ Minimum of 5 years prior experience in pharmaceutical industry in a drug safety / pharmacovigilance global setting + Experience in developing procedural ... Ensures adequate training support to all functional areas within Patient Safety & Pharmacovigilance (PSPV) in a Pharmacovigilance (PV) regulated environment.… more
- System One (Madison, NJ)
- …Life Sciences, Information, or similar background (Bachelors, Masters) + 5+ years Drug Safety / Pharmacovigilance experience + Advanced Tableau, Spotfire, ... Job Title: Pharmacovigilance Reporting Analyst Location: Lawrenceville, NJ Hours/Schedule: Hybrid...Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug ) + Strong PowerPoint, Word, and Excel Skills +… more
- Ascendis Pharma (Princeton, NJ)
- …2 days remote. Key Responsibilities + Assists Head of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate compliance ... information pertinent to product safety . + Supports the development of safety surveillance and risk management plans for drug development programs. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Minimum of 8 years experience in the pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. ... expert for assigned oncology pharmaceutical / biological / drug -device combined products, accountable for the safety .../ drug -device combined products, accountable for the safety strategy and major safety deliverables for… more
- Takeda Pharmaceuticals (Boston, MA)
- …preferred. + At least 5 years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. ... Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major … more
- Astrix Technology (Chicago, IL)
- …a relevant specialty is preferred. + Minimum of 3 years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology ... ** Drug Safety Physician** Clinical Chicago, IL,...to health authority inquiries. + Stay current with global pharmacovigilance regulations and guidelines to ensure compliance and best… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …+ Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance , SVP Late Clinical Development and the ... working closely with other functional areas such as commercial, regulatory, pharmacovigilance , CMC, early clinical and pre-clinical development in this regard. The… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …+ Ensuring alignment amongst relevant functional groups + Review of report from Drug Safety / Pharmacovigilance , as needed + Preparing for and participating ... in product Scientific Advisory Boards for products both marketed and in development + Complete all company and job-related training as assigned within the required timelines. **Job Requirements:** + Relevant science degree (ie, PhD, PharmD, MD; Master's degree… more
- Nestle (Bridgewater, NJ)
- …Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety , pharmacovigilance , manufacturing, engineering ... automation, regulatory compliance, quality management and compliance, medical information, or clinical trials applications. + IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- … Pharmacovigilance Scientist with the following duties: Facilitate ongoing safety surveillance for assigned products, assisting with data collection and ... Signal Evaluation Reports, and Health Authority responses; Contribute to safety -related deliverables associated with new drug applications, benefit-risk… more
- Takeda Pharmaceuticals (Boston, MA)
- …Company-wide patient safety expert for assigned pharmaceutical / biological / drug -device combined products, accountable for the safety strategy and major ... and develop risk management plans including risk minimization measures to address specific safety concerns related to the drug in development or a product… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Global Pharmacovigilance (PV) Scientist** **What you will do** Let's do this. Let's change ... this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for...guidance of GSO + Support activities related to new drug applications and other regulatory filings + Assist GSO/… more
- Sumitomo Pharma (Raleigh, NC)
- …English. **Education and Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience in oncology ... Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health… more
- Amgen (Washington, DC)
- …Analytics Center (DAC). Observational research (OR) makes important contributions to drug development, commercialization, and safety evaluation. OR gives ... products. + Designs and implements retrospective database studies in support of safety and pharmacovigilance . + Provides epidemiological input to worldwide… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Proven track record of leadership and strategic management, team development in pharmacovigilance . + Strong understanding of drug development processes and ... President (VP) of GPS Operations is responsible for overseeing the global pharmacovigilance areas of Case Evaluation and Reporting (CER), Quality and Compliance… more
- Boehringer Ingelheim (Ridgefield, CT)
- …review of team output. + Provide updates of the assigned drug 's safety profile to senior management and recommend pharmacovigilance / risk management ... and expert team of physicians in the global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our… more
- Lilly (Indianapolis, IN)
- …Through a deep technical knowledge of the regulatory framework across Pharmacovigilance , Regulatory, Medical, and Product Quality functions, and the design and ... broad network/functional impact: + Lead and conduct risk assessments of Pharmacovigilance , Regulatory, Medical, and Product Quality functions for the generation of… more
- United Therapeutics (Research Triangle Park, NC)
- …across functions. This role is responsible for management of Global Product Safety & Pharmacovigilance business alliance activities and contribution to AA&C ... 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… more
- Amgen (Washington, DC)
- …lead the execution of clinical pharmacology studies including bioequivalence, special safety , food-effect, drug - drug interaction, special population, ethnic ... Doctorate degree (PhD or DNP) OR PharmD OR MD and 2 years of Safety / Pharmacovigilance or Clinical Research experience in a hospital, university or clinical… more
- BeOne Medicines (Emeryville, CA)
- … sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug . Experience Report ... General Description: _The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and… more