- Takeda Pharmaceuticals (Boston, MA)
- …Minimum of 8 years experience in the pharmaceutical industry within Drug Safety/ Pharmacovigilance , with both investigational and marketed products. + Minimum 3 years ... people management experience and/or proven leadership experience in managing a global, matrix team. + Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit /… more
- Amgen (Los Angeles, CA)
- …required to gain access to therapy + Partner with Safety and Pharmacovigilance (PV). Report Adverse Event (AE)'s and product complaints through medical information ... + MaintaincasehistoryforallU.S.patients,enteringrelevantnotesfromthehub,the pharmacy, callstoinsurance, patient support programs, physiciansandnurses, andthe patients and families + Maintain and update patient status to track reimbursement and shipping status… more
- Astellas Pharma (Northbrook, IL)
- …. Collaborate within Development: o Development o Regulatory Affairs o Pharmacovigilance . Collaborate with divisions outside of Development: o Market Access ... o Commercial o Human Resources o Legal o Ethics & Compliance **Qualifications** **Required** Educational Background: + US: Doctorate Degree in Health-Related Sciences: ie: MD, PhD, PharmD, DNP, DO Years of Experience: + Minimum 5 years scientific/medical… more
- J&J Family of Companies (Raritan, NJ)
- …field. + Safeguard patient safety. Support Sr. Medical Director in Pharmacovigilance activities, reviewing periodic safety reports and adverse events assessment ... related to biologics. + Engage in environmental scanning and competitive analysis, new product development, clinical research, new business development, product training during investigational trials as well as during product launches, and may provide case… more
- Sanofi Group (Morristown, NJ)
- …customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health ... authorities + Collaborate with marketing teams to link sound evidence to brand strategy + Represent as country medical expert in all product label updates and product Company Core Datasheet (CCDS) updates **Data Generation (15%)** + Work with R&D and Clinical… more
- Lilly (Indianapolis, IN)
- …+ Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable. + Serve as an IT systems business quality ... assurance (BQA) representative for IT systems, as assigned. + Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures. + Review and approve as appropriate, documents associated with the development and… more
- Amgen (Washington, DC)
- …Disease portfolio. You will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and ... all product-related decisions and deliverables for assigned products. You will also lead the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). Serve as a member of the Evidence Generation Team… more
- Belcan (Mason, OH)
- …of the product safety are closely monitored and fulfill the pharmacovigilance /regulatory requirements - Requires knowledge and experience in own discipline; still ... acquiring higher level knowledge and skills - Builds knowledge of the organization, processes and customers. If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that… more
- Pfizer (New York, NY)
- …5 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance but with a clear focus on drug safety risk management + Knowledge ... of global safety regulations and guidelines, or equivalent, + Demonstrated experience in global drug safety risk management planning activities and generating RMPs + Demonstrated strength in analytical skills and attention to detail. + Demonstrated strength in… more
- Merck (Lower Gwynedd, PA)
- …Management, Management Process, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance , Regulatory Affairs Compliance, Regulatory Affairs Management, ... Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development {+ 4 more} **Preferred Skills:** **Job Posting End Date:** 06/5/2025 A job posting is effective until 11:59:59PM on the day**… more