- Takeda Pharmaceuticals (Boston, MA)
- …a focus on clinical drug development including but not limited to Pharmacovigilance . + Experience in people leadership, managing matrix teams, and coordinating ... collaboration with cross-functional teams. + Strong strategic thinking, planning, execution, and communication skills. + Global/international experience required, including the ability to collaborate with colleagues and staff in other locations. + Operational… more
- Sanofi Group (Morristown, NJ)
- …Finance, Ethics & Business Integrity, Purchasing, Field Medical, Pharmacovigilance , Clinical Supply, Contract Research Organizations (CROs)/External vendors, ... Investigational Sites, Investigators of ISSs & ESCs and other relevant functions/organizations to ensure rigor and excellence in all aspects of ISS/ESC processes to ensure timely execution operating within relevant internal Policies, SOPs, Corporate Guidance… more
- AssistRx (Des Moines, IA)
- …Compliance Department, including audits, hotline management, internal controls, pharmacovigilance , document control, training, risk management, business continuity, ... CAPA programs, security questionnaires, and trend analysis. + Monitor changes in healthcare and pharmaceutical regulations and ensure organizational adherence. + Collaborate cross-functionally across various departments to ensure effective vendor and… more
- Takeda Pharmaceuticals (Boston, MA)
- …overall safety information for studies and products in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... these issues. + Makes decisions regarding study conduct related to scientific integrity. + **External Interactions** + Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders in… more
- Johns Hopkins University (Baltimore, MD)
- …focus on their translational value in drug discovery, clinical trials, pharmacovigilance , and regulatory science. Tissue-Engineered Systems for Drug Discovery and ... Development - 410.657 This course explores how engineered tissues and organotypic models are revolutionizing the drug development process. Students will learn about sca?old design for drug testing, 3D cultures, organoids, organ-on-chip technologies, and how… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …overall safety information for studies and compound in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... these issues. . Makes final decisions regarding study conduct related to scientific integrity. o **External Interactions** . Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to… more
- Boehringer Ingelheim (Athens, GA)
- …(AE) reporting and request primary and follow-up information. + Provides information to pharmacovigilance and RA according to the study protocol and SOPs. + Ensures ... availability of all final study documentation for audits/inspections (internal compliance or CVM). + Prepares protocols, data, reports, and other documents for submission to regulatory agencies. + Collaborates closely with Regulatory Affairs to align on… more
- Sanofi Group (Morristown, NJ)
- …knowledge in one or two domains (eg, Operational experience in Clinical, Pharmacovigilance , Manufacturing, Site Quality Head for a Manufacturing Site, etc.). + ... Previous experience as a Regulatory Authority Inspector. + Member of International Society for Pharmaceutical Engineering (ISPE), BioPhorum, BSI, and/or Parenteral Drug Association (PDA) with working group experience. + French speaking and/or other languages… more
- Boehringer Ingelheim (Ridgefield, CT)
- …& Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance to implement discovery and development toxicology strategies that enable ... the progression of optimized drug candidates. + When appropriate, take lead to develop plan and lead sub-team for investigative studies to support investigations on mechanisms of toxicity. + Serve as NDS Therapeutic Area lead, and/or provide guidance and… more
- AbbVie (North Chicago, IL)
- …Manufacturing, S&T, Program Management, Regulatory, R&D, Supply Chain, Commercial, Pharmacovigilance , and 3rd Parties. + Ensuring QA/regulatory compliance for all ... assigned products(s). This includes management of QA project/initiatives to define AbbVie processes and develop AbbVie Quality Systems to support device and combination product quality compliance. + Direct QA responsibility for assigned Quality Systems,… more
Recent Jobs
-
Marine Technician I, II, or III
- Louisiana Department of State Civil Service (Chauvin, LA)
-
Police Officer Intern
- University of Colorado (Colorado Springs, CO)
-
Public Finance Attorney - Vice President, Assistant General Counsel
- JPMorgan Chase (New York, NY)
-
Assistant Professor or Higher Pediatric Hematology/Oncology (Peds)
- Texas Tech University Health Sciences Center - El Paso (El Paso, TX)