Senior Medical Director - Patient Safety

Added
5 hours ago
Type
Full time
Salary
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Related skills

pharmacovigilance regulatory submissions nda psur dsur

πŸ“‹ Description

  • Lead safety strategy for late-stage oncology products within the Product Safety Team (PST).
  • Ensure safety across the product lifecycle: surveillance, signal detection, risk management, and
  • Collaborate with PK, toxicology, regulatory, clinical development, and medical affairs to guide
  • Interpret regulations related to pharmacovigilance and author PV documents; lead periodic reporting
  • Mentor and coach team members; contribute to publications and safety leadership initiatives.
  • Engage cross-functionally in a fast-paced environment with strong teamwork and communication.

🎯 Requirements

  • MD/DO with 2+ years of internal medicine/patient management; PhD or Clinical Pharmacology
  • 2-5 years of Pharmacovigilance/Clinical Development in pharma; experience supporting regulatory
  • Oncology patient safety experience required; ability to lead cross-functional teams and present
  • Strong analytical and writing skills for technical documents; regulatory knowledge in PV is

🎁 Benefits

  • AbbVie offers a comprehensive package including paid time off, medical/dental/vision insurance, and
  • Eligible to participate in long-term incentive programs.
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