[Hiring] Associate Director, Medical Safety (Scientist) @Jazz Pharmaceuticals

Role Description

The Associate Director, Medical Safety (Scientist) is a key member of the Medical Safety team. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to:

• Leading cross-functional safety management teams (SMTs) and driving safety strategy for responsible product/program.
• Ensuring that processes and procedures are up to date to meet regulatory requirements and inspection readiness.
• Driving signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
• Effectively communicating with members of the interdisciplinary team regarding ongoing signal evaluation.
• Ensuring that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates.
• Producing accurate and fit for purpose evaluation documents with clear conclusions, as required.
• Leading the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate.
• Authoring or providing guidance for the production of risk management plans (RMPs).
• Providing strategic input into regulatory requests / responses.
• Delivering clinical safety input into clinical development program.
• Leading the medical safety contributions of global regulatory submissions for new products, formulations or indications.
• Participating in and/or leading internal safety surveillance meetings as well as joint safety meetings with licensing partners, as needed.
• Providing medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements.
• Escalating issues / concerns to senior management in a timely and appropriate manner.
• Mentoring and training junior members of the Medical Safety team.

Qualifications

• At least 6 years of experience in drug safety, including at least 4 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.

Requirements

• 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/technical discipline and experience.

Benefits

• Medical, dental and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.
• Discretionary annual cash bonus or incentive compensation (depending on the role).
• Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.