Director, Medical Safety Scientist

About the role

The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, providing leadership, line management, and/or mentorship for the junior safety scientists within the Medical Safety organization. This role leads, oversees, and coordinates all Medical Safety activities for respective TAs/products as well as the Medical Safety organization as a whole.

Responsibilities

• Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
• Ensures that 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 the assessment and prioritization of safety concerns.
• Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation.
• Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required.
• Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate.
• Authors or provides guidance for the production of risk management plans (RMPs).
• Provides strategic input into regulatory requests / responses.
• Delivers clinical safety input into clinical development program.
• Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications.
• Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing partners, as needed.
• Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements.
• Escalates issues / concerns to senior management in a timely and appropriate manner.
• Mentors and trains junior members of the Medical Safety team.

Qualifications

• At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / 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, as well as 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 / databases.

Skills

• Strong leadership and mentoring skills.
• Proven ability to manage and prioritize multiple projects simultaneously.
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Experience with regulatory submissions and safety reporting.

Benefits

Jazz Pharmaceuticals offers a comprehensive benefits package including medical, dental, and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our benefits offerings, please visit here.