Director, Medical Safety Scientist

Jazz Pharmaceuticals; Philadelphia (Philadelphia County); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement savings plan

Flexible paid vacation

Job summary

Jazz Pharmaceuticals is seeking a Director, Medical Safety (Scientist) in Philadelphia, PA. This key role will lead the Medical Safety team, ensuring robust safety governance and driving innovation in medical safety. The successful candidate will mentor junior scientists and oversee drug safety activities, ensuring compliance with regulatory standards.

Minimum requirements include at least 8 years of experience in drug safety and a relevant degree in life sciences. The position offers a comprehensive benefits package, including medical and retirement plans.

Qualifications

• 8+ years in drug safety, including 5 years in surveillance or risk management.
• Expert knowledge of pharmacovigilance regulations.
• Ability to lead interdisciplinary teams effectively.

Responsibilities

• Lead cross-functional safety management teams for product safety strategy.
• Ensure compliance with regulatory requirements for safety processes.
• Authoring risk management plans and aggregate safety reports.

Skills

Drug safety

Pharmacovigilance regulations

Medical writing

Signal management

Team leadership

Education

Degree in life sciences (BS, BA, MSc, or PhD)

Tools

MedDRA

Safety databases

Windows applications

Job description

Director, Medical Safety (Scientist)

The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, providing leadership, line management, and mentorship for junior safety scientists within the Medical Safety organization. In close collaboration with the Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees, and coordinates all Medical Safety activities for the respective therapeutic area or product franchise as well as the Medical Safety organization as a whole. The role is responsible for ensuring up-to-date processes and procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, risk management, and driving innovation initiatives within the Medical Safety organization. It also contributes to regulatory submission safety strategy.

Essential Functions

• Leads cross‑functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
• Ensures processes and procedures are up to date to meet regulatory requirements and inspection readiness.
• Drives signal management process using available methodologies, including making recommendations for assessment and prioritization of safety concerns.
• Effectively communicates with interdisciplinary team members regarding ongoing signal evaluation.
• Ensures available safety information is evaluated to meet internal and external requirements, including labeling updates; produces accurate evaluation documents with clear conclusions.
• Leads coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections.
• Authors or provides guidance for the production of risk management plans (RMPs).
• Provides strategic input into regulatory requests and responses.
• Delivers clinical safety input into clinical development programs.
• Leads medical safety contributions of global regulatory submissions for new products, formulations or indications.
• Participates in and/or leads internal safety surveillance meetings and joint safety meetings with licensing partners.
• Provides medical safety input into creation or review of Safety Data Exchange Agreements and other pharmacovigilance agreements.
• Escalates issues or concerns to senior management in a timely manner.
• Mentors and trains junior members of the Medical Safety team.

Required Knowledge, Skills, and Abilities

Minimum Requirements

• At least 8 years of experience in drug safety, including at least 5 years in surveillance or risk management.
• Ability to independently search clinical safety and literature databases for relevant information.
• Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management.
• Excellent medical writing skills and proven ability to effectively lead interdisciplinary teams.
• In-depth knowledge of medical and drug terminology, as well as the clinical development process.
• Familiarity with MedDRA and safety databases; proficient with Windows applications and ability to learn new programs or databases.

Required/Preferred Education and Licenses

• Requires a degree (e.g., BS, BA, MSc, or PhD) or professional qualification in a life science field (e.g., nursing or pharmacy) or a relevant scientific or technical discipline.

Benefits

The successful candidate will also be eligible to participate in various benefits offerings, including medical, dental, vision insurance, retirement savings plan, and flexible paid vacation. For more information on our benefits offerings, please visit https://careers.jazzpharma.com/benefits.html.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.