- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …quality plan with specialty and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by ... procedures through partnership with stakeholders and QA line functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance, PVQA… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines ... on real-world evidence, and creating hope for all facing illness. As a Manager , Drug Safety Data, you will be responsible for managing and analyzing safety… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and ... quality management activities with key partners impacting the global Regeneron PV system. Furthermore, the GVP QML Sr.... Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at… more
- Sumitomo Pharma (Columbus, OH)
- …CTSA Associate Manager is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will be responsible for ... and audits. + Global safety planning and coordination member to support global initiatives. + Collaborates with Quality on corrective action and preventative… more
- Chiesi (Cary, NC)
- Global RA Manager Date: Aug 30, 2024 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance & Regulatory Affairs ... (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and...different. Every one of us is Chiesi." **Purpose** The Global RA Manager supports the Global… more
- Chiesi (Cary, NC)
- Global Regulatory Affairs Manager Date: Sep 14, 2024 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance & ... (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and...consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded **B Corp Certification**… more
- Takeda Pharmaceuticals (Boston, MA)
- …submission of high- quality aggregate safety reports, in compliance with requisite global and local regulations and requirements. As part of the Patient Safety & ... therapies to patients worldwide. Join Takeda as a Senior Manager , Aggregate Safety Reporting in Cambridge, MA, where you...report and other functional deliverables are completed with high quality . + Responsible for global leadership and… more
- Takeda Pharmaceuticals (Boston, MA)
- …document repositories per Medical Affairs SOPs and processes. + Coordinate with Pharmacovigilance , Quality and Regulatory Affairs to respond to external audits ... as the therapeutic area operational lead for interfacing with internal stakeholders ( Global , Regional and Local Medical Leads, TA Medical Heads) and external… more
- Amgen (Thousand Oaks, CA)
- …your best work alongside other innovative, driven professionals in this meaningful role. ** Quality Compliance Manager , Safety & Medical Quality ** **Live** ... Development teams in GxP audits from business partners. + Support R&D Quality governance bodies in the clinical development, pharmacovigilance and/or research… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- Description: Drug Device Combination Product Manager is a position within the Global Quality Management department. This position is a Corporate Quality ... or defect and assess across products and/or device associations. + Partner with Global Product Safety and Pharmacovigilance to assess complaint and AEs for… more
- Bristol Myers Squibb (Princeton, NJ)
- …resolve respective queries regarding product safety. Provide expertise for the improvement of the Global Quality Database & Global Safety System for medical ... more: careers.bms.com/working-with-us . Employer: Bristol-Myers Squibb Company Position: Sr. Manager , Medical Device Safety (Ref: 4185) Location: 3551 Lawrenceville… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Product Complaint Manager is responsible for being the Subject Matter Expert on the product complaint and adverse events/product complaint ... but are not limited to interaction with medical and non-medical contact centers, quality and investigation sites to facilitate correct, quality and timely… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Drug Safety Global Safety Team (GST) Chair (Medical Director). The Manager , Drug Safety will perform signal management process activities for assigned products, ... product development, registration, and post-market support + Strong knowledge of global regulatory requirements related to pharmacovigilance and drug safety.… more
- BeiGene (San Mateo, CA)
- …experience, including individual study design and filing plans + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than 10% ... decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal… more
- BeiGene (Emeryville, CA)
- …Qualifications:** + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than ... decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal… more
- Gilead Sciences, Inc. (Seattle, WA)
- …possible, together. **Job Description** Job Description You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions or vendors ... R&D. You will provide strategic, expert advice and consultation on R&D quality , risk and continuous improvement with impact across cross-functional Good Practices.… more
- Chiesi (Cary, NC)
- Ad Promo Manager , Americas Regulatory Affairs, Rare Diseases Date: Sep 5, 2024 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: R&D, ... Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Cary,...(Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and… more
- Novo Nordisk (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... and Oversees Patient Safety (PS) employees' onboarding and on-the-job training for pharmacovigilance as well as Safety training conducted for internal and external… more
- Chiesi (Cary, NC)
- Lead Data Manager Date: Sep 14, 2024 Department: Global Clinical Development Job Type: Direct Employee Team: R&D, Pharmacovigilance & Regulatory Affairs ... (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and...consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded **B Corp Certification**… more
- Daiichi Sankyo Inc. (Albany, NY)
- …relevant to the marketplace, competition and the marketing team to the District Manager . + Notifies the Medical Affairs Pharmacovigilance immediately of any ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more