- University of Miami (Miami, FL)
- …The CRSA works closely with clinical research, regulatory affairs, and pharmacovigilance teams to maintain the safety and compliance of investigational products. ... CORE RESPONSIBILITIES + Review and evaluate Serious Adverse Event Reports (SAERs) and Adverse Events of Special Interest (AESIs) for compliance with regulatory reporting and funding entity requirements. + nsure that reported SAER and AESI event reports are… more
- Takeda Pharmaceuticals (Boston, MA)
- …project management, clinical monitoring, data management process, regulatory affairs, pharmacovigilance , etc.) to enable meaningful dialogue within Takeda and with ... partners. + Proven experience in Alliance/Partnership excellence: deep understanding/experience of building, maintaining, and closing partnerships including tools/methods. + Expertise in the ability to perform root cause analysis, develop corrective actions,… more
- Takeda Pharmaceuticals (Boston, MA)
- …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 the context of overall development… more
- BeOne Medicines (San Mateo, CA)
- …clinical operations, legal, compliance, new product planning, safety/ pharmacovigilance , molecular diagnostics, marketing, sales, and translational research. ... The incumbent will play a key role in establishing BeOne Medicines as a valued collaborator and best-in-class biopharmaceutical company. **Territory Includes:** (SC, GA, FL, AL, MS) **Essential Functions of the job:** + Work with Cross-functional teams to… more
- BeOne Medicines (Emeryville, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... **Essential Functions of the job:** + Protocol concepts, synopses, and amendments + Informed consent documents + Investigator Brochures + Clinical study reports + Abstracts, posters and manuscripts + Clinical sections of INDs (and equivalent applications),… more
- NTT America, Inc. (NY)
- …discovery, clinical trials, regulatory quality and compliance, medical affairs, pharmacovigilance , manufacturing and supply chain, pharma sales and marketing. We're ... a partner who's there for our client's transformation journey - from strategy and delivery to achieving business outcomes. Our clients include many of the Global Life Sciences companies. Learn more about how we partner with our Life Sciences clients:… more
- AbbVie (North Chicago, IL)
- …for future opportunities. The Associate Director (AD) of Epidemiology in Pharmacovigilance & Patient Safety leads the scientific strategy for pharmacoepidemiology ... and real-world evidence to support product development and safety across therapeutic areas. They will design and interpret studies, contribute to regulatory submissions, and provide expertise in regulatory pharmacoepidemiology and real-world study methods.… more
- BeOne Medicines (San Mateo, CA)
- …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 Medicines USA, Inc. as a valued collaborator and best-in-class biopharmaceutical company. **Territory Includes:** OH, IN, KY, WV, VA, TN, MD, DE **,** **Essential Functions of the Job:** + Work… more
- AbbVie (Irvine, CA)
- …health authority meetings. + Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + Bachelors degree in the sciences; advanced degree (eg, MS, PhD, PharmD) preferred. + Ability to provide input and direction to clinical research with appropriate supervision. + At least 5 years of clinical… more
- Sanofi Group (Morristown, NJ)
- …benefit-risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team + Implements strategies to identify, ... monitor and resolve clinical program/trial issues. + Responsible for medical monitoring for a study or clinical program as well as reviewing and monitoring study data. + Provide appropriate medical input & support for all activities related to clinical studies… more