- Takeda Pharmaceuticals (Cambridge, MA)
- …translational sciences, statistics, programming, outcomes research and epidemiology, and patient safety & pharmacovigilance ) bring their expertise to our global ... clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with other functional… more
- Bausch + Lomb (Montgomery, AL)
- … Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance /GPSS and Drug /Device Safety , and Clinical ... the successful completion of these studies. May serve as the primary project team representative for Clinical Operations. **Major areas of Responsibility** **:**… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences, and ... clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics… more
- Takeda Pharmaceuticals (Boston, MA)
- …quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance ) bring their expertise to our ... be accountable for study/program level delivery + Effectively drive and influence project teams towards seamless delivery while enabling and making decisions +… more
- Sanofi Group (Cambridge, MA)
- …science organization, and various R&D functions such as patient safety /pharmocovigilance, patient focused drug development, portfolio management, global ... project deliverables requiring EGDS expertise, including innovations in pharmacovigilance , portfolio management, patient-centric early development including diversity in… more
- Lilly (Indianapolis, IN)
- …equivalent experience. + 5+ years experience supporting drug development areas (eg, Safety , Clinical, Project Management, IT, etc.). + 5+ years of prior ... functions across the company to leverage learnings, resources, and capabilities. Assurance of Drug Safety Regulatory Compliance + Maintain safety systems to… more
- Sanofi Group (Cambridge, MA)
- …Collaborate with Global Project Heads, Clinical Research Director, Safety Officer and Pharmacovigilance , Translational Medicine, Regulatory Affairs, ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...risk mitigation plans in collaboration with clinical operations and project management. + Ensure harmonization of study documents and… more
- ICON Clinical Research (Blue Bell, PA)
- …to ensure protocol adherence and quality delivery of study objectives. + Collaborate with Drug Safety teams to assess Serious Adverse Events and contribute to ... our Medical Directors play a pivotal role in our project teams and our company. Your medical expertise will...the development of Safety Management Plans, Pharmacovigilance Plans, and Risk… more
- Edgewell Personal Care (Allendale, NJ)
- …and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance . + Proven ability to communicate, influence and ... (FDA, Health Canada, TGA, and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements. + Maintains thorough… more
- Takeda Pharmaceuticals (Boston, MA)
- …and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post-marketing safety data management). + ... that align with the Takeda values. They will liaise with Takeda pharmacovigilance and medical leaders to ensure alignment across functional areas and stakeholder… more