- Parexel (Oklahoma City, OK)
- …comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team ... with clients, and contribute to the continuous improvement of our pharmacovigilance processes. **Key Accountabilities:** **General** + Maintaining a good working… more
- Organon & Co. (Plymouth Meeting, PA)
- …Commercial, Legal, Compliance, Privacy, Procurement, Business Technology, Quality & Audit, and Pharmacovigilance at all levels of our business. + Maintain a vigilant ... proprietary insights. + Lead the insights and analytics world-wide Pharmacovigilance processes, including annual training packages, due-diligence processes, record… more
- CSL Behring (King Of Prussia, PA)
- …Opportunity:** Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance , as the **Senior Manager, ICSR Quality** , you will have Individual ... the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma… more
- BeOne Medicines (Emeryville, CA)
- …integrated Benefit/Risk assessments. **Promote and Advance the Field of Pharmacovigilance ** + Responsible for effective execution, communication and influence with ... organizational effectiveness and productivity. + Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity.… more
- CSL Behring (King Of Prussia, PA)
- …if required. . Close collaboration with WAVES team, IT, International Pharmacovigilance (IPV) & Capability Building and other interface functions to identify ... or similar. + Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience. + Global … more
- Organon & Co. (Plymouth Meeting, PA)
- …clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance , Chemistry, Manufacturing and Controls (CMC), medical affairs and ... for the general medicines portfolio of products. + Support Drug Safety and Pharmacovigilance with activities such as review of non-clinical literature for new risks,… more
- CSL Behring (King Of Prussia, PA)
- …You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case ... Required** Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience Global … more
- Lundbeck (Deerfield, IL)
- …internal stakeholders (Commercial, Market Access, Regulatory, Clinical Development, Pharmacovigilance etc.) ensuring clinical and scientific alignment with ... integrated plans + Drive an ambitious external engagement agenda by identifying, developing and maintaining strong networks with key external stakeholders including investigators, thought leaders and healthcare practitioners; foster productive partnerships,… more
- BeOne Medicines (Emeryville, CA)
- …new product planning, clinical business development intelligence, safety/ pharmacovigilance , molecular diagnostics, new markets, and translational research. ... The incumbent will play a key role in the establishment of BeiGene as a valued collaborator and best-in-class biopharmaceutical company while exemplifying BeiGene Core Values. Essential Functions: + Oversee the daily clinical and administrative activities of… more
- Organon & Co. (Plymouth Meeting, PA)
- …in R&D functions (eg, Clinical Research, Early Development, Medical Affairs, Pharmacovigilance , Regulatory Affairs, etc.) + At least three years of experience ... in project management. + Proficient with MS Project, MS Timeline, and all Office products. + A working understanding of and application of principles, concepts, practices, and standards of pharmaceutical project management. + Worked on programs in one or more… more
- CSL Behring (King Of Prussia, PA)
- …cases: Comply with legal requirements and company standards of the PV ( Pharmacovigilance ) tasks and responsibilities. Provide Key information to prevent harm from ... adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorization. The role interfaces with internal stakeholders, contributes to regulatory reports / submissions / queries **Key… more
- Arvinas (New Haven, CT)
- …research physician + Partner with Clinical Operations, Translational Medicine, Pharmacovigilance , Data management and other functional team members at assure ... quality and timely study conduct and monitoring + Provide support as needed for clinical and scientific issues that may arise during study execution + Work closely with biostatisticians and programmers to plan analyses of clinical data + Support data summaries… more
- Parexel (Tallahassee, FL)
- …of the designated Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support - Provide medical input into PV workflows and projects and ... participate in safety processing for studies including medical review of serious adverse events. - Support regulatory safety reporting activities - Ensure client needs and concerns are addressed to ensure customer satisfaction - Actively listen to, solicit and… more
- BeOne Medicines (Emeryville, CA)
- …development intelligence, US Marketing, Global Marketing, US Sales, safety/ pharmacovigilance , molecular diagnostics, new markets, 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 while exemplifying BeOne Core Values Essential Functions: + Oversee the daily 1st line manager activities of the Field Medical… more
- GE HealthCare (IL)
- **Job Description Summary** The Head of Pharmacovigilance at GE HealthCare will lead and oversee all US & Canada (USCAN) pharmacovigilance activities for the ... responsibilities that encompasses strategic planning, implementation, and management of pharmacovigilance systems and processes in compliance with regulatory requirements.… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Manager, Pharmacovigilance Department: Pharmacovigilance Location: Elmwood Park, NJ START YOUR APPLICATION ... About the Job This role reports to the Regional Pharmacovigilance Head - North America. The successful individual will...assist with managing the safety tasks performed by a Pharmacovigilance provider with focus on efficient, accurate and timely… more
- Boehringer Ingelheim (Duluth, GA)
- …Boehringer Ingelheim's high regard for our employees. The Veterinarian, Pharmacovigilance ensures pharmacovigilance compliance with all competent authorities ... US, and submit to appropriate authorities as required. May provide support to Pharmacovigilance (PV) Management in the area of ADE analysis, PV trending and/or… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …like you. Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure ... high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines....IT-related PV projects. + Drive Innovation through AI in Pharmacovigilance : Stay at the forefront of artificial intelligence advancements… more
- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical** is seeking a Medical Director of Pharmacovigilance for a fulltime, Direct Hire role with a pharmaceutical client based in the San ... career, trust **The Experts at Hiring Experts.** **Position:** Director, Pharmacovigilance **Operations Location:** Remote **Department:** Clinical R&D **Employment Type**… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …**Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's ... agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US… more
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