AbbVie

Senior Medical Director, PST Lead-Immunology

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 27, 2020
Ref
2007842
Discipline
Science/R&D, Immunology
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 .

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 and supporting all patient safety activities.

Responsibilities:
  • Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
  • Subject matter expert for safety labelling of assigned products
  • Lead and set the strategy for key pharmacovigilance documents, including but not limited to, safety related components of regulatory submissions, medical safety assessments, regulatory responses
  • 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, governance committees, and senior management
  • Effectively write, review and provide input on technical documents independently
  • Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSUR's, PADER's etc.)
  • Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing including signal detection and evaluation
  • Responsible for implementing risk management strategies for assigned products
  • Proactively engaging, inspiring, coaching and mentoring team and colleagues

Qualifications

Basic:
  • MD / DO with 2+ years of residency with patient management experience
  • Master Public Health is preferred in addition to MD / DO, not required
  • 5 - 8 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
  • Effectively analyze and guide analysis of clinical data and epidemiological information
  • Effectively present recommendations / opinions in group environment both internally and externally
  • Write, review and provide input on technical documents
  • Work collaboratively and lead cross-functional teams
  • Ability to lead cross-functional teams in a collaborative environment
  • Fluency, both written and oral, in English
  • Evaluate and make independent decisions. Ability to work effectively in the situation of uncertainty and complexity, ability to multitask

Key stakeholders:
  • Global Therapeutic Area Head, Therapeutic Area Lead, Medical Safety Evaluation, Vice President Medical Safety Evaluation, Global Medical Affiars Therapeutic Area Heads, Global Regulatory Lead, Project Directors Clinical Development.

Experience/Leadership traits:
  • Ability to work collaboratively with colleagues with different areas of expertise (e.g epidemiology, statistisc)
  • Ability to make independent decisions
  • Ability to influence crossfunctional stakeholders - internal and across industry, and regulatory authorities
  • A clear understanding of PV and clinical development and monitoring clinical trial and post-marketing safety
  • Ability to respect other opinions and be inclusive of the different point of views and be open to the ideas of others

Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 10 % of the Time
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.