- 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
- 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
- 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 (Boston, MA)
- …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
- Sanofi Group (Cambridge, MA)
- …connectivity with leadership across Medical, Patient Safety & Pharmacovigilance , Market Access, New Product Planning, Global Regulatory to align the ... and benefit assessments, modeling and simulation, etc + Knowledge of global public health systems, emerging challenges, patient driven decision-making… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **OBJECTIVE:** + Serves as a senior-level Global Safety Lead (GSL) and Company-wide patient safety expert for assigned ... on timeline or product labeling, ensuring the primacy of patient safety . + Mentors GSLs and PV...and interactions with regulatory authorities worldwide. + Assists the Global Medical Safety Oncology Therapeutic Area Head… 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)
- …and inspection preparedness and supports PVRM during regulatory inspections and audits. + Global safety planning and coordination member to support global ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...checks. + Contributes to standard operating procedures relevant to pharmacovigilance . + Assist with other Safety department… more
- Takeda Pharmaceuticals (Boston, MA)
- …and be a core member of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the ... required. You will define and implement a vision for Patient Safety , enhance medical safety ...and/or CRO including significant experience in operating in a global pharmacovigilance organization. + Minimum of 3… more
- Takeda Pharmaceuticals (Boston, MA)
- …global position for pharmacovigilance risk management processes to maximize patient safety + Provide strategic expertise to cross-functional product team ... on incorporation of the patient 's perspective into benefit-risk activities (eg patient preference studies) + Collaborate with Safety Leads, Clinical Leads,… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety ... and CTAs) in collaboration with cross-functional colleagues. + Provide patient safety input to the clinical development...Support GPSE in the maintenance of a highly effective global safety organization in full compliance to… more
- ThermoFisher Scientific (Cambridge, MA)
- …bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend ... Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the best of my knowledge. **Job Description** Are you looking for a patient -focused, innovation-driven company that will inspire you and empower you to shine? Join ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the best of my knowledge. **Job Description** Are you looking for a patient -focused, innovation-driven company that will inspire you and empower you to shine? Join ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Bayer (Cambridge, MA)
- …making, while continuously implementing the patient 's perspective and always ensuring patient 's safety and benefit; + In preparation for assets entering the ... further seamless clinical development. The IPML is responsible for study medical/ safety aspects and risk-benefit assessments supported by Pharmacovigilance and… more
- Sanofi Group (Cambridge, MA)
- …and various R&D functions such as patient safety /pharmocovigilance, patient focused drug development, portfolio management, global regulatory and digital ... novel project deliverables requiring EGDS expertise, including innovations in pharmacovigilance , portfolio management, patient -centric early development including… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** Are you looking for a patient -focused, innovation-driven company that will inspire you and empower you to shine? Join ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Takeda Pharmaceuticals (Boston, MA)
- …relating to studies in assigned compounds. + Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of ... the best of my knowledge. **Job Description** Are you looking for a patient -focused, innovation-driven company that will inspire you and empower you to shine? Join… more