Job Information
Jazz Pharmaceuticals Inc. Senior Manager Pharmacovigilance Assurance in Harrisburg, Pennsylvania
Reference #: R009346 Brief Description: 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 supportfor Good Clinical Practice, Good Distribution Practice, Good Manufacturing Practices, and other Marketing Authorization Holder inspections where there are PV system touchpoints. Essential Functions/Responsibilities
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 ield 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.