Associate medical director, medical safety in Worcester

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.

Brief Description: Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

Essential Functions/Responsibilities:

• The Associate Medical Director / Global Safety Physician is responsible for implementing the global safety strategy and monitoring the overall safety profile for Jazz Pharmaceuticals products (investigational and marketed) throughout its lifecycle.
• This includes generating all major pre- and post-marketing safety deliverables including signal, benefit-risk evaluation and risk management activities.
• This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities.
• This individual, under supervision from the Senior Medical Director in Medical Safety, will work together with PV staff in managing the safety assessment of products, including review of aggregate safety analyses and scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders.
• The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Required Knowledge, Skills, and Abilities:

• Understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP).
• Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems.
• Med DRA trained and working knowledge of Med DRA and WHO Drug coding dictionaries.
• Ability to manage multiple tasks with deadlines in fast-paced working environment.
• Requires a high level of initiative and independence.
• Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.
• Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, Power Point and Word.

Required/Preferred Education and Licenses:

• MD required (or equivalent); medical licensure in at least one state preferred; clinical research and/or fellowship training in internal medicine or neuroscience, hematology/oncology or other relevant specialty is a plus.
• Minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience.