Director, Medical Safety; Scientist

Overview

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit  for more information.

• 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.

• 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.

• 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.

• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.

• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
• Frequent computer use at workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified…