- AbbVie (Irvine, CA)
- …with corporate policies. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. The position is based onsite in Irvine, CA. Qualifications + Bachelors degree in the sciences; advanced degree (eg, MS, PhD) preferred. + Ability to provide input and direction to clinical research teams with minimal… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …programming, outcomes research and epidemiology, patient safety & pharmacovigilance , digital strategy, library sciences, and data architecture/governance) bring ... their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments + ... Ability to work with a safety system database for purposes of medical case review and simple queries + Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize + Ability to effectively communicate… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …statistics, programming, outcomes research and epidemiology, and patient safety & pharmacovigilance ) bring their expertise to our global program teams and reimagine ... our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of QPTS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda… more
- Orchard Therapeutics (Boston, MA)
- …Clinical Science, Clinical Operations, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance ), Non-Clinical department and Tech Ops / CMC department as ... necessary. . Participate in business development initiatives for new programs if relevant. . Some international travels (mostly to the UK/EU) will be required. Requirements Required knowledge and experience . PharmD or PhD in a scientific discipline preferred.… more
- Sanofi Group (Seattle, WA)
- …relevant products in the Vaccine portfolio and pipeline. + Good knowledge of pharmacovigilance and local regulatory process and its impact on the Vaccine portfolio + ... Strong business acumen, understanding importance of and being able to build strategic plans and implement Medical initiatives. + Seen as role model, upholding integrity and ethics values and adhering to high standards **Why Choose Us?** + Bring the miracles of… more
- AbbVie (North Chicago, IL)
- …key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + Medical Doctor (MD) or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a… more
- Bristol Myers Squibb (Los Angeles, CA)
- …with home office medical and clinical development + Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local ... studies, and alert appropriate BMS personnel to any identified Adverse Events + Develop and execute territory and account/TL plans including institution/account referral network building and contribute to execution of regional and national strategy + Act as… more
- Astellas Pharma (Northbrook, IL)
- …into regional and global strategy + Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as ... applicable + Lead scientific review of investigator sponsored research (ISR) proposals in the TA; may chair Regional ISR Committee, as applicable + Provide medical expertise related to new product licensing and acquisition opportunities for the US + Foster a… more
- Sanofi Group (Cambridge, MA)
- …deliverables requiring EGDS expertise, including innovations in pharmacovigilance , portfolio management, patient-centric early development including diversity ... in clinical trials, digital biomarkers, and novel clinical trial designs + Drive development and scaling of advanced statistical tools and frameworks in collaboration with the DevAI initiative team to accelerate evidence generation and decision support. For… more