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.

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.

Requirements

• 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.

Qualifications

• Required: 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.

Skills

• 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.

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 click here: here.