Medical Director, Late Stage Oncology-Product Safety Team Lead (Remote)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Purpose:
To lead Product Safety Teams (PST) and support one or more products as the PST Lead, ensuring that
the safety profile of one or more products is adequately monitored and characterized throughout the
product lifecycle (e.g., surveillance, signal detection and evaluation, risk management, etc.).
Interpreting regulations related to pharmacovigilance supporting all patient safety activities.

Responsibilities:
• 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
combination products
• Lead, oversee, and set the strategy for key pharmacovigilance documents, including but not
limited to, medical safety assessments, regulatory responses, risk management plans,
periodic safety reports (DSURs, PBRERs/PSURs, PADERs), etc.
• Lead and oversee safety surveillance and pharmacovigilance activities for products in clinical
development and marketed products, applying current regulatory guidance as appropriate
• Analyze and interpret aggregate safety data and communicate these analysis and
interpretation to cross-functional teams and regulatory authorities.
• Effectively and independently write, review, and present technical documents .
• 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.
• Master Public Health is preferred in addition to MD / DO, not required.
• 2-5 years of Pharmacovigilance / Clinical