- Takeda Pharmaceuticals (Boston, MA)
- …, Rare Disease & PDT with the following duties: serve as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned ... INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues; provide patient safety input to the clinical development program for assigned… more
- Parexel (Boston, MA)
- Join our dynamic Patient Safety team as a **Senior Physician** where you'll leverage your medical expertise to ensure the safety of patients in clinical ... pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across...compliance. **About the Role** As a **Senior Physician in Patient Safety ** , you'll serve as the… more
- Takeda Pharmaceuticals (Boston, MA)
- …oversight of key domains such as Programming, Statistical Computing, Global Evidence, Quantitative Pharmacology & Translational Sciences, Pharmacovigilance ... Python), advanced analytics, real-world evidence, quantitative pharmacology, translational sciences. Pharmacovigilance technologies ( safety databases, signal detection, case… more
- Takeda Pharmaceuticals (Boston, MA)
- …programming, outcomes research and epidemiology, patient safety & pharmacovigilance ) bring their expertise to our global program teams and reimagine ... of my knowledge. **Job Description** **Objective / Purpose:** Takeda is a global , values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and… more
- Takeda Pharmaceuticals (Boston, MA)
- …duties: Deliver pharmacovigilance (PV) reporting & analytic solutions for Takeda Patient Safety & Pharmacovigilance (PSPV); Identify and develop methods ... understanding of such tools and techniques. Identify and document Global Pharmacovigilance reporting end-user system needs and...identify and remediate issues with the configuration of the global safety database and its associated data.… more
- Sumitomo Pharma (Boston, MA)
- …to ensure consistency, regulatory compliance, and operational excellence. + Support global safety planning and coordination, and maintain relationships with ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...the US (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases,… more
- Takeda Pharmaceuticals (Boston, MA)
- …assigned compounds. + **Trial Medical Monitoring** + Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of ... my knowledge. **Job Description** Are you looking for a patient -focused, innovation-driven company that will inspire you and empower...to shine? Join us as a Vice President , Global Clinical Lead - Solid Tumor in our Cambridge… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …critical part in maintaining the integrity of clinical trial data and ensuring patient safety by verifying adherence to regulatory requirements and internal ... The ** Global Quality Audit Manager** is responsible for planning,...**Stakeholder Engagement** : Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance , and other functions to ensure alignment on quality… more
- Sanofi Group (Cambridge, MA)
- …you'll drive breakthroughs that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a ... consumers. The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in... and Medical Quality documents (QDs) in line with global quality standards + Promote a single consistent approach… more
- Sumitomo Pharma (Boston, MA)
- …team members to manage the benefit/risk profile of assigned products and ensure patient safety . + Assist in signal detection activities including data assembly, ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements… more