Jazz Pharmaceuticals is hiring: Director, Medical Safety (Scientist) in Philadel

If you are a current Jazz employee please apply via the Internal Career site. 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 www.jazzpharmaceuticals.com for more information. The Director, Medical Safety (Scientist) is a key member of the Medical Safety team, and provides leadership, line management, and/or mentorship for the junior safety scientists within Medical Safety organization. In close collaboration with Medical Safety Physician and/or Medical Safety Scientist line manager, this role leads, oversees and coordinates all Medical Safety activities for respective TA/ product franchise as well as Medical Safety organization as a whole. This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management and/or driving innovation initiatives within Medical Safety organization. In close collaboration with Medical Safety Physician, this role is also responsible for contributing to regulatory submission safety strategy. Other responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. Essential Functions • 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. Required Knowledge, Skills, and Abilities Minimum 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. 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. #LI-DM1 #LI-Remote 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. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $200,000.00 - $300,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.

In Summary: The Director, Medical Safety (Scientist) is a key member of the Medical Safety team . This role is responsible for ensuring up to date processes / procedures for safety governance, signal management, clinical surveillance, periodic safety reporting, and risk management .

En Español: Si usted es un empleado actual de Jazz, por favor solicite a través del sitio Internal Career. Jazz Pharmaceuticals es una compañía biofarmacéutica global cuyo objetivo es innovar para transformar la vida de los pacientes y sus familias. Nos dedicamos al desarrollo de medicamentos que cambian la vida para las personas con enfermedades graves a menudo con opciones terapéuticas limitadas o sin ellas. Tenemos una cartera diversa de medicamentos comercializados, incluidas terapias líderes para trastornos del sueño y epilepsia, y un portafolio creciente de tratamientos contra el cáncer. Nuestro enfoque centrado en el paciente y basado en la ciencia permite avances pioneros en investigación y desarrollo a lo largo de nuestra sólida línea de actividades terapéuticas innovadoras en oncología y neurociencia. Esta función es responsable de garantizar los procesos / procedimientos actualizados para la gobernanza de seguridad, gestión de señales, vigilancia clínica, informes periódicos sobre la seguridad y manejo de riesgos y/o impulsar iniciativas de innovación dentro de la organización de Seguridad Médica. En estrecha colaboración con Medical Safety Physician, este papel también es responsable del aporte a la estrategia reguladora de presentación de seguridad. • Asegura que la información de seguridad disponible se evalúa para cumplir con los requisitos internos y externos, incluida la identificación de la necesidad de actualizaciones de etiquetado. Produce documentos de evaluación precisos y adecuados al propósito con conclusiones claras, según sea necesario. • Conocimiento experto de las regulaciones de farmacovigilancia en relación con los informes de seguridad agregados, planes de gestión del riesgo y la administración de señales. • Excelente habilidad médica para escribir, así como capacidad comprobada para dirigir eficazmente equipos interdisciplinarios. • Un conocimiento profundo de la terminología médica y farmacéutica, al igual que el proceso de desarrollo clínico. #LI-DM1 # LI-Remote Jazz Pharmaceuticals es un empleador de igualdad de oportunidades/acción afirmativa y todos los solicitantes calificados recibirán una consideración para el empleo sin importar la raza, color, religión, sexo, origen nacional, estado de discapacidad, estatus de veterano protegido o cualquier característica protegida por la ley. FOR US BASED CANDIDATES ONLY jazz pharmaceutical, Inc. está comprometida con prácticas justas y equitativas de compensación y nos esforzamos por proporcionar a los empleados paquetes totales de indemnización que sean competitivos en el mercado. Para este papel, el rango salarial completo es: $200,000.00 - $300,000.00. El candidato exitoso también puede ser elegible para recibir un bono en efectivo o una compensación de incentivo anual discrecional (dependiendo del papel), de acuerdo con los términos del Plan Global de Bonos En Efecto O Plan Incentivo de la Compañía, así como subvenciones de equidad discrecionales de conformidad con el plan de incentivos a largo plazo de Jazz.El candidato seleccionado también podrá participar en varias ofertas de beneficios, incluidos pero no limitados al seguro médico, dental y de visión, plan de ahorro de jubilación 401k y vacaciones pagadas flexibles. Para obtener más información sobre nuestras Ofertas de Beneficios haga clic aquí: https://careers.jazzpharma.com/benefits.html..