Senior Medical Director, Oncology Patient Safety

AbbVie; Irvine (CA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Long-term incentive programs

Paid time off

Zusammenfassung

AbbVie seeks a Pharmacovigilance Lead within the Product Safety Team to guide late‑stage oncology programs. You will set safety strategies, oversee surveillance, signal detection, risk management, and contribute to pre‑NDA and NDA submissions with cross‑functional partners.

You will lead cross‑functional teams, mentor colleagues, and ensure regulatory compliance while shaping dose selection and safety monitoring in clinical trials.

Qualifikationen

• MD/DO with internal medicine residency required; PhD or Clinical Pharmacology fellowship preferred in addition to MD/DO, not required
• 2–5 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
• Previous experience supporting regulatory submissions (IND/BLA submissions) is required
• Oncology patient safety experience is required

Aufgaben

• Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
• Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products
• Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission – safety component
• Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
• Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed
• Effectively write, review and provide input on technical documents independently
• Over oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.)
• Responsible for implementing risk management strategies for assigned products
• Proactively engaging, inspiring, coaching and mentoring team and colleagues
• Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader
• Strong team player, able to adapt and work in a fast pace environment
• Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Kenntnisse

MD/DO with residency

Pharmacovigilance experience

Clinical development experience

Regulatory submissions experience

Oncology patient safety experience

Ausbildung

MD/DO degree

Jobbeschreibung

AbbVie seeks a Pharmacovigilance Lead within the Product Safety Team to guide late‑stage oncology programs. You will set safety strategies, oversee surveillance, signal detection, risk management, and contribute to pre‑NDA and NDA submissions with cross‑functional partners.

You will lead cross‑functional teams, mentor colleagues, and ensure regulatory compliance while shaping dose selection and safety monitoring in clinical trials.