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About the Role
The Associate Director, Medical Safety (Scientist) is a key member of the Medical Safety team, responsible for ensuring up-to-date processes for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management, and/or driving innovation initiatives within the Medical Safety organization. This role also contributes to regulatory submission safety strategy in collaboration with the Medical Safety Physician and/or Medical Safety Scientist line manager.
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 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.
- Participates in and/or leads 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 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.
Skills
- Signal management
- Clinical surveillance
- Periodic safety reporting
- Risk management
- Medical writing
- Leadership
- Communication
- MedDRA
- Safety databases
Location
- Remote
Work Type
- Full-time
Experience Level
- Associate Director
- 6 years of experience in drug safety
- 4 years of experience in surveillance / risk management
Education Level
- 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.
Salary/Compensations
- $156,000.00 - $234,000.00
Benefits
- Discretionary annual cash bonus or incentive compensation
- Discretionary equity grants
- Medical insurance
- Dental insurance
- Vision insurance
- 401k retirement savings plan
- Flexible paid vacation
About the Company
- Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for people with serious diseases, often with limited or no therapeutic options.
- The company has a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
- Jazz's patient-focused and science-driven approach powers pioneering research and development advancements across its 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.
- Visit www.jazzpharmaceuticals.com for more information.
Equal Opportunity
- 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.