The Associate Director, Safety Surveillance and Aggregate Reports will be a key member of the Medical Safety team. In close collaboration with Safety Physicians, responsibilities include Signal Management activities, production of aggregate safety reports, provision of high-level scientific expertise in the safety evaluation and risk management of assigned products, and global leadership / representation of medical
safety within the company.
- 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) and authors relevant sections.
- Authorship and/or guidance of 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.
- May provide medical safety input into creation / review of Safety Data Exchange Agreements.
- Escalates issues / concerns to senior management in a timely and appropriate manner.
- Mentor and train junior members of the team in signal evaluation methodology, risk management, preparation of safety reports or other documents.
Required Knowledge, Skills, and Abilities
- At least 10 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.
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/technical discipline.
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- 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 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.