AbbVie

Group Medical Director, Medical Safety Evaluation

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 26, 2020
Ref
2007618
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 .

An effective leader and collaborator. Is capable of strategizing and guiding senior and junior safety physicians and other health care professionals in their work to ensure safety of products across several therapeutic areas through the product lifecycle (e.g. ICSR review, surveillance, signal detection, validation, and assessment, reviewing regulatory documents). Can effectively interact with senior PV leaders. Directs all functionality of the Medical Safety Review including processes, staff, and work products.

Responsibilities:
  • Provides strategy, guidance, and review of safety surveillance and pharmacovigilance activities for products across therapeutic areas and across a product lifecycle (clinical development and marketed products).
  • Interprets regulations related to pharmacovigilance supporting all patient safety activities.
  • Understands and applies principles of pharmacology, chemistry, and non-clinical toxicology to effectively guide the conduct safety surveillance for pharmaceutical/biological/drug-device combination products.
  • Leads and sets the strategy for key pharmacovigilance documents (e.g. Summary of Clinical Safety, safety assessments, regulatory responses, PSURs, DSURs, PADERs, risk management plans) by applying current regulatory guidance.
  • Guides safety teams during NDA, EU, PMDA and other regulatory submissions.
  • Effectively presents recommendations/opinions in group environment both internally and externally.
  • Effectively reviews and provides independent and critical input on safety documents.
  • Ensures compliance with relevant pharmacovigilance regulations and company standards.
  • Manages Associate Medical Directors, Medical Directors, Senior Medical Directors, and other health care professionals (as applicable): performance and talent management, coaching, and development.
  • Supports audits, inspections and CAPA investigations, as necessary.

Qualifications

Basic:
  • MD / DO with 2+ years of residency with patient management experience.
  • Master Public Health is preferred in addition to MD / DO, but not required.
  • 10+ years of Pharmacovigilance / Clinical Development and Individual Case Review (ICSR) experience in the pharmaceutical industry. Fluency, both written and oral, in English.
  • Evaluate and make independent decisions

Experiences/leadership traits
  • Is an effective and independent decisionmaker and is an effective communicator
  • Can work cross-functionally and collaboratively, and build relationships
  • Collaborative with colleagues with different areas and levels of expertise
  • Influences cross functional stakeholders - internal and across industry and regulatory authorities
  • Has a clear understanding of PV in clinical development/postmarketing, and ICSR review
  • Is respectful of other opinions and is inclusive of differing points of views.
  • Works effectively in the situation of uncertainty and complexity, can multitask.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
No
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.