- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + Provide strategic ... expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support the… more
- Rhythm Pharmaceuticals (Boston, MA)
- …+ Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents ... providers and cross functional internal teams, including clinical, medical, pharmacovigilance and regulatory + In collaboration with Procurement, responsibilities… more
- Takeda Pharmaceuticals (Boston, MA)
- …compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by ... and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance -related change controls. + Provides data insights to emerging… more
- Takeda Pharmaceuticals (Boston, MA)
- …in full compliance to worldwide regulations. + Train and mentor Pharmacovigilance Physicians and Specialists. + Maintain professional knowledge and accreditation by ... + At least 5 years of experience in pharmaceutical industry within Drug Safety/ Pharmacovigilance , with both investigational and marketed products. + At least 3 years… more
- Adecco US, Inc. (Waltham, MA)
- …eligibility criteria. Summarized Purpose: Advanced leadership responsibilities within the Pharmacovigilance (PV) physician team which may include direct line ... organization on significant matters. * Utilizes subject matter clinical and pharmacovigilance expertise, combined with knowledge of the product(s) or therapeutic… more
- Takeda Pharmaceuticals (Boston, MA)
- …CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key ... include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and remediation… more
- Takeda Pharmaceuticals (Boston, MA)
- …or buying of Compliance Services categories, including but not limited to pharmacovigilance services.** You will be assigned to support Takeda's Research & ... and lead Compliance Services categories, including but not limited to pharmacovigilance services.** You will lead competitive procurement, supplier negotiations and… more
- Astellas Pharma (Cambridge, MA)
- …senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance /Medical Safety in the development and maintenance of medical ... publications. -Play a strategic lead role in collaboration with Pharmacovigilance /Medical Safety to ensure optimal standards, processing, collection, and… more
- Bayer (Cambridge, MA)
- …responsible for study medical/safety aspects and risk-benefit assessments supported by Pharmacovigilance and Clinical Science; + Is accountable for the timely ... Cambridge **Division:** Pharmaceuticals **Reference Code:** 843713 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Medical, Oncology, Hematology, Medical Technologist, Pharmacovigilance ,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Clinical Program Quality team and share insights to trends to Clinical Pharmacovigilance and Medical Quality and R&D Quality leadership for proactive risk mitigation ... include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, deviation management, Serious… more