Senior Medical Director, Product Safety Team Lead-Oncology

Company: AbbVie, Inc.
Location: Clearlake
Posted on: April 8, 2021

Job Description:

Senior Medical Director, Product Safety Team Lead-Oncology

• Lake County, United States of America
• Medical
• 2104886 Job Description About AbbVie
  AbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
  
  Leading Product Safety Teams (PST) and support one or more products as the PST Lead under the direction of the Group Lead and TA Head in ensuring safety of one or more products through the product lifecycle (e.g. surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities.--
  • 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
    Qualifications
    
    • MD / DO with 2+ years of residency with patient management experience
    • 5 - 8 years of Pharmacovigilance experience in the pharmaceutical industry
    • 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
      Significant Work Activities
      Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
      Travel
      Yes, 20 % of the Time
      Job Type
      Experienced
      Schedule
      Full-time
      Job Level Code
      E
      Equal Employment Opportunity
      At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
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Keywords: AbbVie, Inc., Santa Rosa , Senior Medical Director, Product Safety Team Lead-Oncology, Healthcare , Clearlake, California