AbbVie Senior Medical Director, Product Safety Lead (Oncology) in Lake County, Illinois
Senior Medical Director, Product Safety Lead (Oncology)
USA, Illinois, Lake County
Leading Product Safety Leads (PST) and support one or more products as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA Head in ensuring safety in one or more products to through surveillance, signal detection, validation and assessment. Interpreting regulations related to pharmacovigilance supporting all patient safety activities.
Key Responsibilities Include:
Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance.
Responsible for 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 analysis and interpretation to cross-functional teams.
Effectively write, review and provide input on technical documents independently.
Oversight and responsibility for leading 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.
Responsible for implementing risk management strategies for assigned products.
Proactively engaging, inspiring, coaching and mentoring team and colleagues.
MD / DO with 2+ years of residency with patient management experience
5 - 8 years of Pharmacovigilance experience in the pharmaceutical industry
Prefer candidate with patient safety experience in oncology therapeutic area
Ability to lead cross-functional team in a collaborative environment
Fluency, both written and oral, in English
Evaluate and make independent decisions
Work collaboratively and lead cross-functional teams
Write, review and provide input on technical documents
Effectively analyze and guide analysis of clinical data and epidemiological information
Effectively present recommendations / opinions in group environment both internally and externally
Master Public Health is preferred in addition to MD / DO, not required
Equal Opportunity Employer Minorities/Women/Veterans/Disabled