- US Tech Solutions (Madison, NJ)
- …Life Sciences, Information, or similar background (Bachelors, Masters) * 5+ years Drug Safety / Pharmacovigilance experience * Advanced Tableau, Spotfire, ... **Title:** ** Pharmacovigilance (PV) Analytics and Reporting Specialist** **Duration :...Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug ) * Ability to organize/curate data and see big… more
- Actalent (Madison, NJ)
- …- Life Sciences Information or similar background Bachelors Masters - 5 years Drug Safety / Pharmacovigilance experience - Advanced Tableau Spotfire Power BI ... Postgres Oracle MS Access Impala SharePoint List etc. - 5 years Drug Safety / Pharmacovigilance experience About Actalent Actalent is a global leader in… more
- Actalent (Boston, MA)
- Reporting to the Director, Drug Safety and Pharmacovigilance Compliance and Operations, you will play a pivotal role in drug safety activities, ... * 2+ years of experience in a pharmaceutical industry setting within Drug safety , Pharmacovigilance , or the equivalent. * Demonstrated experience with… more
- AssistRx (Maitland, FL)
- …Life Sciences, etc.) or equivalent experience required. + 7+ years of experience in pharmacovigilance / drug safety , with 3+ years in a compliance, oversight, ... The Manager, Pharmacovigilance - Front End Operations will lead frontline...to ensure consistent alignment with global regulatory requirements for drug safety , reporting, and risk management. This… more
- Novo Nordisk (Plainsboro, NJ)
- …(eg MD, PhD, PharmD, NP) + A minimum of 10 years of relevant experience in drug safety / pharmacovigilance , or related fields required + Minimum of 6 years of ... experience in mentoring others + In-depth knowledge of North America (US, CA), EU drug safety regulations, CIOMS and ICH guidelines required + Proven track… more
- Adecco US, Inc. (Springfield, NJ)
- …in Europe. **Requirements:** + MD + 10+ years of drug development / drug safety / pharmacovigilance + Experience with Hematology studies + Leadership ... **VP, Global Drug Safety ** Our long-term pharmaceutical client is looking to add a Vice President, Global Drug Safety to their team. Reporting into the… more
- Taiho Oncology (Princeton, NJ)
- …for responsible compounds, as well as regulatory guidelines as they pertain to drug safety / pharmacovigilance . + Responsible for Individual Case Safety ... and Abilities: + Minimum of 5 years of experience in a Pharmacovigilance / Drug Safety environment with substantial experience in managing adverse event… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of professional management experience in PV required - 10+ years of Drug Safety / Pharmacovigilance experience, including both investigational and marketed ... and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that… more
- Bausch + Lomb (Rochester, NY)
- …Person for consumer-related issues escalated by team members + Manage communication within Drug Safety ( Pharmacovigilance ) email box + May collaborate with ... other sources to respond to the post or answer any questions: Regulatory- Pharmacovigilance , R&D, all other Bausch + Lomb sites worldwide, Marketing, Legal + Log… 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
- Sanofi Group (Swiftwater, PA)
- … evaluation reports) **About You** **Experience** : + Working knowledge of drug safety and risk management including industry experience, and understanding ... critical in helping our teams accelerate progress. The Patient Safety & Pharmacovigilance aspiration is to be...Signal & Risk Management: Expertise in the collection of drug safety information from a variety of… more
- Amgen (Washington, DC)
- …with these qualifications. **Basic Qualifications:** Doctorate degree and 2 years of safety / pharmacovigilance experience OR Master's degree and 4 years of ... guidance of GSO + Support activities related to new drug applications and other regulatory filings + Assist GSO... safety / pharmacovigilance experience OR Bachelor's degree and... safety / pharmacovigilance experience OR Bachelor's… more
- CSL Behring (King Of Prussia, PA)
- …with 10+ years of pharmaceutical/biotherapeutics industry experience + Experience in drug safety , pharmacovigilance , quality assurance and compliance ... requirements is desirable. + 5+ years of Medical Affairs Leadership experience + Experience building and leading matrixed teams in a global organization + Experience in biomedical research, scientific analysis and writing + Influential leader who builds… more
- Nestle (Brisbane, CA)
- …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)
- …of experience in people management.** + Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug ... company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will...interpretation of safety data in support of safety update regulatory submissions, investigational and new drug… more
- Ascendis Pharma (Palo Alto, CA)
- …in Palo Alto, California. The team is known for relentlessly delivering to our drug safety internal customers and utilizing the latest trends in technology to ... related systems. + Experience from key technical areas, such as: Argus safety solutions, Argus Analytics, Pharmacovigilance Systems, Argus Product Configuration,… more
- Takeda Pharmaceuticals (Columbus, OH)
- …of experience in people management. + Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug ... company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will...analyses of safety information, in support of safety update regulatory submissions, investigational and new drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …Description** **How you will contribute:** + Senior advisor to the Head, Patient Safety & Pharmacovigilance (PSPV) to develop, drive and implement the overall ... inspection readiness + Oversees the strategy and operational excellence of the Takeda Safety Board Office (TSBO) and Global PV Educational functions + Works with the… more
- ThermoFisher Scientific (Greenville, NC)
- …national and international regulatory authorities + Detailed understanding of the drug development lifecycle spanning clinical trial and post market authorization + ... to present services to sponsors and prepare effective proposals for Pharmacovigilance and Regulatory Affairs activities which include the specific value proposition… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Departments: + Work closely with Integrated Operations (IOPs), BioAnalytical Systems (BAS), and Drug Safety and Pharmacovigilance (DSP) to ensure the EDMS ... meets the needs of all stakeholders. + Facilitate cross-departmental communication and collaboration to enhance system functionality and user experience. Future System Uses: + Analyze, propose, and strategize on future system uses, such as Process Navigator. +… more
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