Senior Medical Director - Patient Safety
AbbVie
August 25, 2026
Remote friendly (South San Francisco, CA)
United States
$182,000 - $346,000 USD yearly
Medical Affairs
Product Safety Team (PST) lead for late stage oncology products. Collaborate with development medical lead to set oncology program strategy. Own safety through the product lifecycle (surveillance, signal detection, validation/assessment, risk assessment/mitigations, tox management). Partner with PK/toxicology, regulatory, clinical development, and medical affairs to guide dose selection/regimen, inclusion/exclusion criteria, and safety monitoring for first-in-clinical trials and PMOS. Interpret pharmacovigilance regulations and lead safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label/label updates, and RMPs.
Responsibilities:
- Conduct safety surveillance using pharmacology/chemistry/non-clinical toxicology knowledge.
- Lead safety surveillance for pharmaceutical/biologic/drug-device combined products.
- Set strategy for key pharmacovigilance documents (medical safety assessments, regulatory responses, risk management plans, NDA/sNDA safety components).
- Apply regulatory guidance for safety surveillance and PV document authorship.
- Analyze/interpret aggregate safety data and communicate to cross-functional teams, leadership, and externally.
- Write/review/provide input on technical documents.
- Lead periodic report strategy (DSURs, PSURs, PADERs, etc.).
- Implement risk management strategies for assigned products.
- Engage/coaching/mentoring; support publications/initiatives.
- Adapt in fast-paced environment.
Qualifications:
- MD/DO with 2+ years internal medicine residency with patient management required; PhD or Clinical Pharmacology fellowship preferred.
- 2–5 years pharma Pharmacovigilance/Clinical Development.
- Prior regulatory submission support (IND/BLA) required.
- Oncology patient safety experience required.
- Ability to analyze clinical/epidemiological data; present recommendations; write/review technical documents; lead cross-functional teams.
Benefits (if eligible): Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.
Responsibilities:
- Conduct safety surveillance using pharmacology/chemistry/non-clinical toxicology knowledge.
- Lead safety surveillance for pharmaceutical/biologic/drug-device combined products.
- Set strategy for key pharmacovigilance documents (medical safety assessments, regulatory responses, risk management plans, NDA/sNDA safety components).
- Apply regulatory guidance for safety surveillance and PV document authorship.
- Analyze/interpret aggregate safety data and communicate to cross-functional teams, leadership, and externally.
- Write/review/provide input on technical documents.
- Lead periodic report strategy (DSURs, PSURs, PADERs, etc.).
- Implement risk management strategies for assigned products.
- Engage/coaching/mentoring; support publications/initiatives.
- Adapt in fast-paced environment.
Qualifications:
- MD/DO with 2+ years internal medicine residency with patient management required; PhD or Clinical Pharmacology fellowship preferred.
- 2–5 years pharma Pharmacovigilance/Clinical Development.
- Prior regulatory submission support (IND/BLA) required.
- Oncology patient safety experience required.
- Ability to analyze clinical/epidemiological data; present recommendations; write/review technical documents; lead cross-functional teams.
Benefits (if eligible): Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.