- Novo Nordisk Inc. (Plainsboro, NJ)
- …health authority regulations and Novo Nordisk requirements in relation to the Pharmacovigilance (PV) process at NNI. This role fulfills the Quality Assurance ... function in processes including, but not limited to, Deviation Handling, Content Control, and Change Control. Additionally, this role provides SME-level input from the affiliate perspective when required. This role also provides direct support for continuous… more
- BeOne Medicines (San Mateo, CA)
- …programs (hereinafter collectively referred as "Programs" below) to ensure all pharmacovigilance activities required in such Programs are performed in an efficient, ... and compliant manner. The position requires an experienced and confident manager who can collaborate with multiple stakeholders internally and externally ensure… more
- CSL Behring (King Of Prussia, PA)
- …to developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager , Regulatory Science? The job is in our King of Prussia, ... strategies align with current and emerging requirements. - **Safety and Pharmacovigilance Intelligence** Monitor, track and analyze global PV regulations, safety… more
- BeOne Medicines (Emeryville, CA)
- General Description: The ** Senior Regional Director (SRD) (US) - Field Medical Directors (FMD) - Solid Tumor, Breast Cancer North America Medical Affairs** will ... team, and supporting national efforts as directed by the National Director. The Senior Regional Director will help oversee the field medical team's support of… more
- BeOne Medicines (Emeryville, CA)
- …**:** The Manager , Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving program-level compliance ... oversight and guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/ Pharmacovigilance , Clinical, CMC, and Regulatory Technology teams. While Regulatory… more
- Parexel (Des Moines, IA)
- **_Parexel FSP has an exciting opportunity for a Clinical Quality Operations Manager ! This is a remote role !_** **Position Purpose:** The Clinical Quality ... Operations Manager (CQOM), in collaboration with the Clinical Quality Operations...(QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is… more
- Parexel (Baton Rouge, LA)
- …trials for local sponsorship as needed with the support of the designated Senior Medical Director/ Global Head of TA (as appropriate) Pharmacovigilance Support ... assigned studies and propose /execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction Business Development… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. Global Safety Senior Manager , Rare Disease **What you will do** Let's do this. Let's ... + Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance ...for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Senior Manager of Product Management in Digital Health supports ... Digital Health, IT, Worldwide and regional Brand Teams, Drug Development, Pharmacovigilance , Regulatory Affairs, Quality and Legal to ensure alignment and connect… more
- Regeneron Pharmaceuticals (Warren, NJ)
- The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing ... relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments +… more
- Nestle (Chicago, IL)
- …Marketing, Technical Operations, Legal, Clinical, Commercial, Medical Affairs, Pharmacovigilance , and Compliance teams. **Key Responsibilities:** * Guide, direct ... and coordinate the strategic labeling/advertising/promotion and planning for company products from a regulatory perspective for pre and post launch campaigns including strategic label development from target product profile (TPP), company core data sheet… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager , Global Safety Database Configuration in our Cambridge, MA office. At Takeda, ... the safety database and helps drive digital transformation in pharmacovigilance by adopting new technologies for automation/intelligence while maintaining regulatory… more
- Insight Global (Conshohocken, PA)
- Job Description The Senior Manager , IT R&D Business Analyst will drive the delivery of technology solutions and digital transformation initiatives within R&D and ... R&D applications and data management solutions (Veeva Quality, RIM, Safety, Pharmacovigilance ) * Strong understanding of GxP environments and Computer System… more
- AbbVie (North Chicago, IL)
- …data pertaining to safety and efficacy of the molecule. As needed, provides senior expert medical judgment in the assessment and reporting of serious adverse events ... strategies at a disease area and platform level. + Acts as a senior -level liaison for opinion leader interactions related to the disease area(s); partners with… more
- Independent Health (Buffalo, NY)
- …on REMS programs and creating/updating SOPs when appropriate. + Work with senior pharmacy technician to train staff on Pharmacovigilance and creating/updating ... support continued improvement. + Work with Compliance, Contract, and Regulatory Manager to facilitate training needs related to accreditation compliance, including… more
- Merck (West Point, PA)
- …to interact with and influence stakeholder subject matter experts and senior leaders + Operational management experience, including capacity planning and scheduling ... right-first-time execution and accelerating batch release. + Experienced and strong people manager with proven track record of build, lead, and inspire effective… more
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