Head of Multiple Myeloma & AML, Oncology - Global Patient Safety
AbbVie · Irvine, CA · 1 mo ago
ManagementFull-time
About the role
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors. Leads Product Safety Teams (PST) and supports one or more products as the PST Lead, ensuring safety through the product lifecycle. Interprets pharmacovigilance regulations to support patient safety activities.
Responsibilities
- Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors, and Executive Medical Directors.
- Leads Product Safety Teams (PST) and supports one or more products as the PST Lead, ensuring safety through the product lifecycle (e.g., surveillance, signal detection, validation, assessment).
- Interprets regulations related to pharmacovigilance supporting all patient safety activities.
- Understands and applies pharmacology, chemistry, and non‑clinical toxicology to conduct safety surveillance.
- Responsible for safety surveillance for pharmaceutical/biological/drug‑device combination products.
- Leads and sets strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses, and risk management plans.
- Applies current regulatory guidance for safety surveillance and authorship of PV documents.
- Analyzes and interprets aggregate safety data and communicates findings to cross‑functional teams.
- Writes, reviews, and provides input on technical documents independently.
- Oversees strategy for periodic reports (PSURs, PADERs, etc.).
- Oversees safety surveillance and pharmacovigilance activities for products in clinical trials and post‑marketing.
- Implements risk management strategies for assigned products.
- Proactively engages, inspires, coaches, and mentors team and colleagues.
- Manages performance and talent management, coaching, and development of Associate Medical Directors, Medical Directors, and Senior Medical Directors.
- Coordinates and oversees safety‑related activities at a product level across multiple indications or related products for the same indication.
- Assesses product safety strategy across the entire program and oversees approval‑related activities.
Qualifications
- MD/DO with 2+ years of residency and patient‑management experience.
- Master of Public Health preferred (in addition to MD/DO) but not required.
- 8‑10 years of pharmacovigilance/clinical development experience in the pharmaceutical industry.
- Ability to effectively analyze and guide analysis of clinical data and epidemiological information.
- Ability to effectively present recommendations/opinions in group settings, both internally and externally.
- Skilled in writing, reviewing, and providing input on technical documents.
- Capable of working collaboratively and leading cross‑functional teams.
- Ability to lead cross‑functional teams in a collaborative environment.
- Fluency in English, both written and oral.
- Ability to evaluate and make independent decisions.
- Ability to work effectively amid uncertainty and complexity, and to multitask.
Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in long‑term incentive programs.