AbbVie Medical Director, Pharmacovigilance in North Chicago, Illinois
Medical Director, Pharmacovigilance
USA, Illinois, Lake County
Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.
Safety surveillance for pharmaceutical / biological / drug-device combined products.
Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, and risk management plans.
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents.
Analyze and interpret aggregate safety data and communicate these analyses and interpretation to cross-functional teams.
Ability to effectively write, review and provide input on technical documents.
Be responsible for the strategy for periodic reports (PSUR’s, PADER’s etc.).
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post-marketing.
Lead and implement a risk management strategy for assigned products.
MD / DO with 2+ years of residency with patient management experience and Master Public Health is preferred in addition to MD / DO but not required.
2 – 4 years of Pharmacovigilance experience in the pharmaceutical industry.
Effectively analyze and guide analysis of clinical data and epidemiological information.
Effectively present recommendation / opinions in group environment.
Write, review and provide input on technical documents.
Self-starting and can work independently. Work collaboratively and lead cross-functional teams
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 15 % of the Time
Job Type: Experienced
Job Level Code: D