Medical Director

Role Summary

Medical Director to lead Product Safety Teams (PST) and support one or more products as the PST Lead, ensuring safety profiles are adequately monitored and characterized throughout the product lifecycle (e.g., surveillance, signal detection and evaluation, risk management). Interpreting regulations related to pharmacovigilance to support all patient safety activities. Location: Open for all AbbVie US office locations.

Responsibilities

• Understanding and application of 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 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 analyses 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

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

Education

• MD/DO degree; Master of Public Health preferred.