Senior Manager Pharmacovigilance Assurance

If you are a 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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

This position primarily provides support to the Clinical and Pharmacovigilance Quality Assurance (CPVQA) function for Pharmacovigilance (PV) Systems in:

• Leading the preparation for, and hosting of Regulatory Authority PV System inspections at Jazz's primary U.S. site, and external audits performed of Jazz.
• Ensuring compliance with global, local and regional PV regulations and Jazz's policies/procedures

Inspection readiness is focused in GVP, but is not limited to GVP and may include support

for Good Clinical Practice, Good Distribution Practice, Good Manufacturing Practices, and other Marketing Authorization Holder inspections where there are PV system touchpoints.

• Partners with PV system stakeholders in R&D, Tech Ops and Commercial to monitor trends in regulatory inspection activities to proactively identify potential areas of risk, and develop proposals to mitigate against such risks.
• Collaborates with local site teams (e.g., IT, Facilities, R&D, Administrative Support, etc.) to ensure logistical support during inspections and audits.
• Prepare subject matter experts, and their back-ups, to present their functions during audits and aid in creating storyboards.
• Work with business to develop appropriate corrective action / preventative action against observations from inspections and audits.
• Track all relevant corrective action / preventative action details from inspections and audits to completion.
• Escalates issues of critical noncompliance and/or lack of urgency in remediation to senior leadership.
• Develop and implement monitoring programs to ensure regulatory requirements for PV/Post- Authorization requirements are complied with and risks are minimized through coordination of internal/external audits.
• Support the development of trending analysis of inspection and audit outcome data to identify business or development program risks. Provide consultative support to the business with the purpose of continuous improvement
• Upon notification of a regulatory inspection or internal audit initiates and supports the inspection team to prepare and submit pre-inspection document requests, logistics, and execution. Preforms inspection host responsibilities when required.
• Ensures that company communications are sent regarding the start and end of inspection activity and provides daily summary to Sr. Leadership.
• Contribute to the development and execution of Global PV/Post-Authorization audit strategy, and implementation within the Quality Management System.
• Coordinate and implement strategic audit plans for pharmacovigilance and post- authorization commitment activities that include service providers, vendors, business partner, and internal audits.
• Evaluate corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement; ensure adequate and timely closure of CAPAs generated from audits.
• Required Knowledge, Skills, and Abilities
• 5+ years working knowledge / experience of pharmaceutical experience
• Knowledge of GVP is required. Knowledge of post-authorization commitment requirements is preferred (Phase IV, PASS Studies) and Managed Access Programs (PSPs/MRPs, Early access etc.) is desirable.
• Knowledge and experience with GCP, GLP, and GDP is a plus.
• Advanced inspection experience with FDA, MHRA (or other EU Competent Authorities); experience with emerging markets Regulatory Authority such as PMDA a plus.
• Ability to work across geographical boundaries with strong leadership and ability to inspire colleagues.
• GVP auditing experience is preferred.
• GVP lead auditor certification is desirable.
• Sound judgment and decision-making skills.
• Must be able to influence and motivate others without authority.
• Action and results orientated.
• Project management skills desirable.
• Required/Preferred Education and Licenses
• Bachelor's degree in a related field is required; Master's degree in management, leadership or scientific discipline a plus.

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 $124,000-$186,000. 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: