Medical Director, Oncology, Global Patient Safety

Job description

Responsible for supporting the Product Safety Lead (PST) 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. Responsibilities • 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 analysis and interpretation to cross-functional teams • Under the guidance of PST Lead write, review and provide input on technical documents • MD / DO with 2+ years of residency with patient management experience required • Master Public Health is preferred in addition to MD / DO • Effectively analyze clinical data and epidemiological information required • Effectively write technical documents with direction • Work collaboratively in a team environment and be self-starting and able to work independently • Ability to effectively present recommendation / opinions in group environment • Fluency, both written and oral, in English About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.