- Lundbeck (Deerfield, IL)
- …+ Excellent working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management, REMS programs. + Detailed understanding and ... ability to apply concepts of legal/regulatory requirements and guidelines to the pharmacovigilance business + Ability to work well with modest supervision in a… more
- Sanofi Group (Morristown, NJ)
- …needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Identifies data collection opportunities ... during stakeholder interactions and reports these using approved processes. + Maintains awareness of clinical trial activity within territory and suggests clinical trials sites as requested. + Responds to unsolicited requests regarding interest in investigator… more
- Merck (Rahway, NJ)
- …data that is tracked and managed within regulatory, clinical & pharmacovigilance processes + Demonstrated ability to collaborate with senior management and ... information workers on the importance and need for master data management _I_ governance + Experience in working within relevant Industry Trade Associations/Health Authorities with the ability to influence topics/outcomes in the best interest of the Company +… more
- Bristol Myers Squibb (Phoenix, AZ)
- …Adverse Events (AEs) and fully understand and comply with BMS Pharmacovigilance SOPs regarding identification and reporting timelines + Contributes to managing ... external communication when significant safety issues arise, with the well-being of patients being the goal + Understands and adheres to the BMS Standards of Business Conduct and Ethics, all Company policies and procedures including those that apply to all… more
- Sanofi Group (New Orleans, LA)
- …relevant products in the Vaccine portfolio and pipeline. + Good knowledge of pharmacovigilance and local regulatory process and its impact on the Vaccine portfolio + ... Strong business acumen, understanding importance of and being able to build strategic plans and implement Medical initiatives. + Seen as role model, upholding integrity and ethics values and adhering to high standards **Why Choose Us?** + Bring the miracles of… more
- Sanofi Group (Morristown, NJ)
- …strategy and issue escalation with the Therapeutic Area Head (TAH) and Pharmacovigilance (PV) Head + Oversee third-party safety providers during acquisition and ... development periods to ensure Sanofi safety governance processes are integrated **Internal and external safety expert** + Provide PV and risk management expertise to internal and external customers + Safety expert for product + Maintain knowledge of product,… more
- Lilly (Indianapolis, IN)
- …of CGxP's, across research and development, commercial manufacturing, pharmacovigilance , information quality. **Additional Preferences:** + Demonstrated strategic ... thinking, learning agility, analytical skill, and complex analysis. + Experience in leading strategic and business planning activities. + Experience across manufacturing functions and technologies preferred. + Demonstrated experience in IT solution delivery… more
- BeOne Medicines (Boston, MA)
- …clinical operations, legal, compliance, new product planning, safety/ pharmacovigilance , molecular diagnostics, marketing, sales and translational research. ... The incumbent will play a key role in the establishment of BeOne as a valued collaborator and best-in-class biopharmaceutical company. **Territory Includes:** Vermont, New Hampshire, Maine, Massachusetts, Connecticut, Rhode Island Essential Functions: + Work… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and associated reports to internal customers such as R&D, Clinical, Pharmacovigilance , Regulatory and Marketing departments. The Knowledge Services Specialist 2, ... specifically participates in evaluating external information resources for the company's online and electronic collections. Works with scientists and technical colleagues to develop key word searches and assist with in-depth research assignments. Assists with… more
- J&J Family of Companies (Horsham, PA)
- …+ 6+ years of relevant experience is required. + Medical writing or Pharmacovigilance (PV) experience is required. + Working knowledge of medical concepts and ... familiarity with safety activities in drug development and post marketing and global safety health authority requirements is required. + Ability to understand and analyze complex medical-scientific data from a broad range of sources is required. + Ability to… more