- Sanofi Group (Waltham, MA)
- …+ Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for DSUR, SMTs) + May represent Sanofi ... **Job Title:** Statistical Project Leader, Deputy Director, Global Biostatistics Sciences **Location**...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- BeOne Medicines (San Mateo, CA)
- …Medical Monitoring Plans, CSRs (incl. China ADR Summary) and other relevant project /study documents and answer ad-hoc safety queries from ethics committees ... sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report… 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)
- …with an advanced understanding of requirements for clinical trials and drug development, regulatory submissions, pharmacovigilance reporting and medical ... as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle. This role reports to the… more
- Bayer (Cambridge, MA)
- …further seamless clinical development. The IPML is responsible for study medical/ safety aspects and risk-benefit assessments supported by Pharmacovigilance and ... the full value chain from pre-D1 up to hand-over to late-stage drug development (following Proof-of-Concept and the decision to enter pivotal studies). The… more
- Sanofi Group (Morristown, NJ)
- … strategy and issue escalation with the Therapeutic Area Head (TAH) and Pharmacovigilance (PV) Head + Oversee third-party safety providers during acquisition and ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...Communicate with and represent PV analyses and positions within project /productteams, in safety governance and benefit-risk governance… more
- Haleon (Warren, NJ)
- …digital projects) within assigned therapeutic category and/or business unit and represent safety function at project teams and other relevant cross-functional ... with a risk-proportionate framework for product vigilance, the **Associate Director, Consumer Safety Science** is accountable for developing the safety strategy… more
- Sanofi Group (Cambridge, MA)
- …(SMTs) + Communicate with and represent PV analyses and PV position within project /product teams, in safety governance and benefit-risk governance activities and ... **Job Title:** Global Safety Officer **Location** : Cambridge, MA **About the...of medicine? The race is on to speed up drug discovery and development to find answers for patients… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The Executive Director, Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across ... various regions, offering guidance and support to each product safety team in critical areas such as individual case...expectedness of the adverse event in relation to the drug . Ensure all relevant data and findings are incorporated… more
- ThermoFisher Scientific (Wilmington, NC)
- …find cures for cancer. **Location/Division Specific Information** Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs ... regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific… more