🌎
This job posting isn't available in all website languages

About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

If grabbing a link is not working for you, simply copy the URL at the top of this page to share with your referrals.

Medical Director/Product Safety Team Lead (Oncology)

📁
Medical
📅
1904795 Requisition #
Join our Talent Community

 Responsible for supporting the Product Safety Leads (PST) and potentially 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.

  • 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
  • Ability to effectively write, review and provide input on technical documents
  • Lead 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 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

 

Previous Job Searches

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions
Copyright © 2018 AbbVie Inc. North Chicago, Illinois, U.S.A
Unless otherwise specified, all product names appearing in this internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. No use of any AbbVie trademark, trade name, or trade dress in this site may be made without the prior written authorization of AbbVie Inc., except to identify the product or services of the company.