Associate Director, Medical Safety (Scientist)

Job Summary

Jazz Pharmaceuticals is seeking an Associate Director, Medical Safety (Scientist) to lead safety and pharmacovigilance activities for its oncology pipeline in Mount Laurel Township, Burlington County, US. This senior role combines scientific expertise with strategic oversight to ensure patient safety and regulatory compliance.

Key Responsibilities

• Lead the medical safety team in the assessment, analysis, and reporting of adverse events for oncology clinical trials.
• Develop and implement safety monitoring plans, risk mitigation strategies, and signal detection processes.
• Collaborate with cross‑functional teams—including clinical development, regulatory affairs, and biostatistics—to integrate safety data into trial designs and product submissions.
• Prepare and review safety sections of IND, NDA, and BLA submissions, ensuring alignment with FDA, EMA, and other global regulations.
• Mentor junior scientists and provide scientific guidance on causality assessment, case narratives, and aggregate safety reporting.
• Represent Jazz in external safety forums, advisory boards, and regulatory meetings.

Qualifications & Requirements

• PhD or PharmD with extensive experience in medical safety, pharmacovigilance, or clinical pharmacology, preferably in oncology.
• Minimum 8 years of progressive responsibility in safety data analysis, signal detection, and regulatory submissions.
• Strong knowledge of FDA, EMA, ICH guidelines and experience preparing safety documentation for global submissions.
• Proven leadership skills with the ability to influence cross‑functional teams and drive safety‑focused decision making.
• Excellent written and verbal communication skills; ability to present complex safety data to senior leadership and external agencies.

Compensation

Salary: $171,606.84 per year (fixed). Jazz offers a competitive benefits package, including health, dental, vision, 401(k) match, and generous paid time off.

How to Apply

Current Jazz employees should apply through the internal career site. External candidates can submit their application via the WeHired.Agency portal.

Frequently Asked Questions

What experience is required for the Associate Director, Medical Safety role?

At least 8 years in medical safety or pharmacovigilance, preferably in oncology, with a PhD or PharmD and proven leadership experience.

Is this position open to candidates outside the United States?

The role is based in Mount Laurel Township, Burlington County, US, and candidates must be authorized to work in the United States.

What benefits does Jazz Pharmaceuticals offer?

Jazz provides health, dental, vision insurance, 401(k) matching, paid time off, and other employee wellness programs.