Senior Medical Director - Patient Safety

📋 Description

• Lead safety strategy for late-stage oncology products within Product Safety Team.
• Oversee pharmacovigilance activities across lifecycle; safety surveillance, signal detection, risk
• Guide dose selection, safety monitoring and trial design input with cross-functional partners.
• Lead safety components of pre-NDA and NDA/sNDA submissions and regulatory responses.
• Interpret regulatory PV guidance and author PV documents; write/ review technical safety documents.
• Mentor team, engage cross-functional teams, and co-author publications when possible.

🎯 Requirements

• MD/DO with 2+ years internal medicine experience; PhD or Clinical Pharmacology fellowship preferred
• 2-5 years Pharmacovigilance/Clinical Development in pharma; regulatory submission experience
• Oncology patient safety experience required; strong ability to analyze clinical data and present
• Ability to lead cross-functional teams and work in fast-paced environments.
• Experience writing/reviewing PV documents and PSURs/DSURs; ability to mentor others.

🎁 Benefits

• AbbVie benefits package including PTO, health/dental/vision insurance, 401(k).
• Eligibility for long-term incentive programs; compensation varies by location and role.