Medical Director

Role Summary

Medical Director responsible for leading Product Safety Teams (PST) and supporting one or more products as PST Lead to ensure safety profile monitoring and characterization throughout the product lifecycle, including surveillance, signal detection, evaluation, and risk management. Interprets regulations related to pharmacovigilance and supports all patient safety activities.

Responsibilities

• Understand and apply pharmacology, chemistry, and non-clinical toxicology to conduct safety surveillance.
• Oversee safety surveillance for pharmaceutical/biological/drug‚Äìdevice combination products.
• Lead, oversee, and set the strategy for key pharmacovigilance documents (medical safety assessments, regulatory responses, risk management plans, 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 analyses to cross-functional teams and regulatory authorities.
• Write, review, and present technical documents independently and effectively.
• Implement risk management strategies for assigned products.
• Proactively engage, inspire, coach, and mentor team members and colleagues.

Qualifications

• MD/DO with 2+ years of residency with patient management experience.
• Master of Public Health is preferred in addition to MD/DO, not required.
• 2‚Äì5 years of pharmacovigilance/clinical development experience in the pharmaceutical industry.
• Ability to analyze and guide analysis of clinical data and epidemiological information.
• Ability to present recommendations/opinions in group settings internally and externally.
• Ability to write, review, and provide input on technical documents.
• Ability to work collaboratively and lead cross-functional teams; capable of leading cross-functional teams in a collaborative environment.
• Fluency in English (written and oral).
• Ability to evaluate and make independent decisions; comfortable working in uncertainty and complexity and multitasking.

Skills

• Pharmacovigilance
• Clinical development
• Signal detection and risk management

Education

• MD/DO required; MPH preferred (not required).

Additional Requirements

• Location: Open to all AbbVie US office locations.