AbbVie

Medical Director, Medical Safety Review

Employer
AbbVie
Location
Lake County, Illinois
Posted
Oct 01, 2021
Ref
2116767
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

  • 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

Qualifications
  • 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
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.