- Takeda Pharmaceuticals (Boston, MA)
- … pharmacovigilance (PV) reporting & analytic solutions for Takeda Patient Safety & Pharmacovigilance (PSPV); Identify and develop methods for statistics ... to support the department's data needs; Solve business problems in drug safety which provide an increased understanding of such tools and techniques. Identify… more
- Sanofi Group (Cambridge, MA)
- …drive breakthroughs that could turn the impossible into possible for millions. The Patient Safety & Pharmacovigilance (PSPV) aspiration is to be a cutting-age ... our patients and consumers. The Quality Documents Expert is part of the Pharmacovigilance Quality (PVQ) department in PSPV function working in an international and… more
- Parexel (Boston, MA)
- …this pivotal role, you'll perform comprehensive medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned ... all Key Performance Indicators (KPIs) for the process + Function as pharmacovigilance representative/ safety scientist + Attend/support Bid defense meetings +… more
- Takeda Pharmaceuticals (Boston, MA)
- …a core member of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice President, ... Description** **About the role:** Join Takeda as a Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical … more
- Takeda Pharmaceuticals (Boston, MA)
- …in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and ... **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ At least 5 years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance , with both investigational and marketed products. + At least 3 ... **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- Sanofi Group (Cambridge, MA)
- …including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. ... including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups.… more
- Parexel (Boston, MA)
- …**medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + **Exceptional ... **Medical Monitor** for gastroenterology studies, ensuring scientific integrity and patient safety + Provide expert medical oversight throughout the clinical trial… more
- Sumitomo Pharma (Boston, MA)
- …clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. ... monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences, and ... interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety , Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and… more