- BeOne Medicines (Boston, MA)
- …leadership, clinical operations, legal, compliance, new product planning, safety / pharmacovigilance , molecular diagnostics, marketing, sales and translational ... research. The incumbent will play a key role in the establishment of BeOne as a valued collaborator and best-in-class biopharmaceutical company. **Territory Includes:** Vermont, New Hampshire, Maine, Massachusetts, Connecticut, Rhode Island Essential… more
- Sumitomo Pharma (Boston, MA)
- …for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout product lifecycle ... strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety… more
- Astellas Pharma (Cambridge, MA)
- …with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and Pharmacovigilance /Medical Safety in the development and maintenance of ... specialty publications. -Play a strategic lead role in collaboration with Pharmacovigilance /Medical Safety to ensure optimal standards, processing, collection,… more
- Sanofi Group (Waltham, MA)
- …(CROs) + Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, safety surveillance) + ... May represents Sanofi Vaccines BIOS group externally in interactions and meetings with Regulatory Authorities, expert panels, statistical experts, independent data monitoring committees + May act as the lead statistician at clinical trial level and provides… more
- Sumitomo Pharma (Boston, MA)
- …and effectiveness checks. + Contributes to standard operating procedures relevant to pharmacovigilance . + Assist with other Safety department activities as ... (CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will...Manager works closely with the Information Management (IM) and Safety Science groups as part of a matrix team… 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 ... record for assigned compounds. + Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. + Responsible for evaluation of external interactions in… more
- United Therapeutics (Boston, MA)
- …plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more
- Rhythm Pharmaceuticals (Boston, MA)
- …as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle. This role reports to the ... + Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents… more
- Sanofi Group (Cambridge, MA)
- … strategy and issue escalation with the Therapeutic Area Head (TAH) and Pharmacovigilance (PV) Head + Oversee third-party safety providers during acquisition and ... **Job Title:** Global Safety Officer, Oncology **Location** : Cambridge, MA, Morristown,...development periods to ensure Sanofi safety governance processes are integrated **Internal and external … more