- AbbVie (North Chicago, IL)
- … pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate reports. 4. Apply current regulatory ... pipeline and considered for future opportunities. Medical Directors within the Patient Safety , Epidemiology and Quality team are responsible for the following: 1.… more
- United Therapeutics (Springfield, IL)
- …plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… more
- AbbVie (Mettawa, IL)
- …communications, training, and clinical value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). ... Participates in the design and execution of clinical trial safety , product safety and risk management plans....TA preferred. + Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. + Must have… more
- AbbVie (Mettawa, IL)
- …closely with cross-functional teams - including Commercial, Market Access, Regulatory, Safety , and Clinical Development - to support the product lifecycle, from ... ethical standards. . Collaborate with Regulatory Affairs, Legal, Compliance, and Pharmacovigilance teams to ensure adherence to internal processes, policies, and… more
- AbbVie (Mettawa, IL)
- …(medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). ... role in a TA preferred. + Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. + Must have an in-depth understanding of… more
- Bristol Myers Squibb (Chicago, IL)
- …Adverse Events (AEs) and fully understand and comply with BMS Pharmacovigilance SOPs regarding identification and reporting timelines + Contributes to managing ... external communication when significant safety issues arise, with the well-being of patients being the goal + Understands and adheres to the BMS Standards of… more
- AbbVie (North Chicago, IL)
- …integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is ... key regulatory discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality… more