- Takeda Pharmaceuticals (Boston, MA)
- … regulatory requirements worldwide + Supports and advocates the vision and mission of Global Patient Safety & Pharmacovigilance (PSPV) as a member of the ... Management, Risk Management & Benefit Risk, Medical Review and Aggregate Safety Reports in compliance with Pharmacovigilance regulatory requirements worldwide… 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 ...with regulatory authorities worldwide. + Assists the Global Medical Safety GI Therapeutic Area Head in assessing… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Serves as a senior-level Global Safety Lead (GSL) and Company-wide patient safety expert for assigned oncology pharmaceutical / biological / drug-device ... on timeline or product labeling, ensuring the primacy of patient safety . + Mentors GSLs and PV...with regulatory authorities worldwide. + Assists the Global Medical Safety Oncology Therapeutic Area Head in assessing… more
- Takeda Pharmaceuticals (Boston, MA)
- …a key role in Global Labeling and works under the direction of the Head of Global Labeling and is: + Responsible, for providing regulatory expertise, strategic ... and guidance to internal stakeholders, including Clinical, Device Development, Pharmacovigilance , Legal, Scientific, Commercial, to ensure successful development and… 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
- Rhythm Pharmaceuticals (Boston, MA)
- …management + Provide proactive GCP QA support for clinical development to ensure patient safety , data integrity, compliance, and operational excellence + Develop ... to enhance clinical development practices. This role will report into the Head , GCP/GLP Quality Assurance. Responsibilities and Duties + Actively collaborate with… more