Reference #: R009595 If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.

The Sr. Manager, Medical Safety is a key member of the Medical Safety team within the Pharmacovigilance department.In close collaboration with Safety Physician(s), responsibilities include signal management activities, production of aggregate safety reports (eg., PBRERs, DSURs, PADERs), provision of high-level scientific expertise in the safety evaluation and risk management of assigned products, and representation of Medical Safety within the company (eg., leading Safety Management Team). Essential Functions

• Leads the coordination of aggregate safety reports (eg., PBRERs, DSURs, PADERs) and authors relevant safety sections.
• In conjunction with Safety Physician, drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns.
• Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates.
• In collaboration with Safety Physician, produces accurate and fit for purpose Signal Evaluation Reports with clear analyses and conclusions.
• Participates in and/or leads internal safety surveillance meetings as well as joint safety meetings with licensing partners, if required.
• Represents Medical Safety within the company (eg., leading Safety Management Team, participating on other cross-functional teams).
• In conjunction with Safety Physician, authors and/or guides project teams on the production of risk management plans.
• In conjunction with Safety Physician, provides strategic input into regulatory requests related to safety.
• In conjunction with Safety Physician, provides 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.
• May serve as business process owner for relevant procedural documents and contribute to process improvement initiatives.
• Participates in internal audits and Health Authority inspections, as required. Required Knowledge, Skills, and Abilities

Minimum Requirements * At least 5 years of experience in PV, including at least 3 years of experience in surveillance and/or risk management PV functions. * Advanced knowledge of PV regulations regarding aggregate safety reports, signal management, and risk 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. * Proficiency 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 or experience. Description of Physical Demands

Occasional mobility within office en ironment.

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.

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: $134,400.00 - $201,600.00 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.

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.