- 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
- Sumitomo Pharma (Columbus, OH)
- …collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements ... a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to… 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)
- …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 (Harlem, GA)
- …country-specific regulations, and company SOPs while managing safety concerns with Global Drug Safety and Pharmacovigilance teams. * Scientific & Medical ... submissions. * Cross-Functional Excellence: Work closely with commercial, regulatory, pharmacovigilance , CMC, early clinical, and pre-clinical teams to shape and… 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
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Global Pharmacovigilance (PV) Senior Scientist** **What you will do** Let's do this. Let's ... 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …(3) years of post- baccalaureate experience. Must have experience with/in: + Drug safety , medical writing, signal detection, scientific background, clinical ... Assessment Physician leading signal detection activities for a product's emerging safety profile. Prepare and write Pharmacovigilance sections of aggregate … 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 (Columbus, OH)
- …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
- AbbVie (North Chicago, IL)
- …in the regulations in relation to the science for the benefit of drug safety . + Strong leadership presence and communication skills. Strong influencing ... . Job Description Purpose: This position reports into the Safety Operations Product Leadership team which is part of...the healthcare industry and a strong understanding of the drug development process. + Minimum of 3 years of… 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
- 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
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