- Aequor (Thousand Oaks, CA)
- …of case management and medical review SOPs and regulatory requirements for Pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug ... employees and vendor staff (if applicable) on ICSR medical review Participate in Safety Assessment Team (SAT) if applicable Perform other duties related to the… more
- Sanofi Group (Cambridge, MA)
- … patient safety experience and clinical data. + Collaborate within Global Pharmacovigilance for optimizing signal detection, benefit risk assessment and ... and implementation of project-level strategy plan + Provide expertise on translational patient safety based on biomarkers, precision medicine, and real-world… more
- Amgen (Washington, DC)
- …operations. This person will also provide scientific and compliance expertise as needed to Global Patient Safety . Applicable tasks may vary by product(s) ... transform the lives of patients while transforming your career. ** Global Pharmacovigilance (PV) Senior Scientist** **What you... documents and regulatory responses in collaboration with the Global Safety Officer (GSO) + Search and… more
- Bristol Myers Squibb (San Diego, CA)
- …for interactions with global regulatory authorities and stakeholders, advocating for patient safety . + Engage with external experts, scientific bodies, and ... Strategy and Oversight + Develop and lead the global pharmacovigilance strategy to ensure proactive risk...in a matrixed, cross-functional environment. + Demonstrated commitment to patient safety and ethics in medical practice.… more
- Orchard Therapeutics (Boston, MA)
- …Company. The Head of Pharmacovigilance will be responsible for leading Pharmacovigilance for Orchard, driving patient safety , regulatory compliance, and ... of commercial drug safety databases and managing software supporting global Pharmacovigilance operations + Gene therapy/ultra rare/orphan diseases background… more
- Eurofins (Kalamazoo, MI)
- …sciences to clients worldwide. The position will contribute to a Global Pharmacovigilance team s\with the collective responsibilities of addressing ... will ensure deliverables and embracing priorities that align with promoting patient safety , effective data analysis, and cross-functional communication and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of critical documents (eg, protocols, ICFs, IBs, etc.); Assist with the presentation of patient safety risks and SMT recommendations on safety issues to ... other labelling documents; Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations. 10%… more
- Takeda Pharmaceuticals (Boston, MA)
- …& Purpose:** + Ensures adequate training support to all functional areas within Patient Safety & Pharmacovigilance (PSPV) in a Pharmacovigilance ... Minimum of 5 years prior experience in pharmaceutical industry in a drug safety / pharmacovigilance global setting + Experience in developing procedural… more
- 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
- Sumitomo Pharma (Raleigh, NC)
- …of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + Experience managing safety data, expedited ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases,… more
