Manager Medical Safety (Remote)

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 (https : / / www.jazzpharmaceuticals.com) for more information.Brief Description : The Manager, Medical Safety is a key member of the Medical Safety team within Global Regulatory and Drug Safety (GRADS) department. In close collaboration with Safety Physician(s), senior Medical Safety Scientists, and other stakeholders, responsibilities include supporting signal management activities, preparation of aggregate safety reports (eg., PBRERs, DSURs, PADERs), supporting the safety evaluation and risk management of assigned products, and representation of Medical Safety within the company (eg., supporting safety management team activities, supporting clinical development activities).Essential Functions

• Applies professional / technical expertise in preparation of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant safety sections.
• In conjunction with Safety Physician, supports signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns and helps produce accurate and fit for purpose evaluation documents with clear conclusions.
• Participates in and / or leads internal safety surveillance meetings as well as joint safety meetings with licensing partners / other departments. Assists with preparing meeting materials.
• In conjunction with Safety Physician, collaborates with project team / cross-functional teams on the production / update of risk management plans (RMPs) and other relevant safety reports / contributions.
• In conjunction with Safety Physician, supports PV contributions to global regulatory submissions for new products, formulations, or indications.
• May provide safety input into creation or review of Safety Data Exchange Agreements, and other documents requiring input from Medical Safety Scientist.
• May be responsible and / or serve as business process owner for relevant projects, improvement initiatives, and / or procedural documents.
• Supports in internal audits and Health Authority inspections, as required.Required Knowledge, Skills, and AbilitiesMinimum Requirements
• At least 2 years of experience in PV function. Experience in surveillance, clinical safety, aggregate safety reporting and / or risk management PV functions is highly preferred.
• Working knowledge of PV regulations regarding aggregate safety reports, signal management, and risk management.
• Proficiency in medical writing, communication, and planning / organizational skills
• Knowledge of medical and drug terminology, as well as the clinical development process.
• Familiarity with MedDRA and safety databases.
• Proficiency with Windows applications, and ability to learn new programs / databases.Required / Preferred Education and Licenses
• Requires a degree (e.g., BS, BA, MSc, PharmD 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.FOR US BASED CANDIDATES ONLYJazz 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 : $120,000.00 - $180,000.00Individual 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 (https : / / careers.jazzpharma.com / benefits.html) .

Salary : $120,000 - $180,000