Manager PV Compliance

Research & Development      ·       Remote / Harrisburg / Boston / Raleigh / Springfield / Sacramento / Olympia       ·       Full time

 Multiple Locations: Remote Non Sales-USA, California; Harrisburg, Pennsylvania; Boston, Massachusetts; Raleigh, North Carolina; Springfield, Illinois; Sacramento, California; Olympia, Washington

 Categories: Research & Development

 Req ID: 6762

Job Description

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.

The Manager, Pharmacovigilance Compliance is responsible for executing PV Compliance activities based on relevant regulations, procedures, and contractual requirements.   Through implementation of quality and compliance tracking tools/reports, oversight strategy and relationship management, this role will support the development and management continuous improvements across the pharmacovigilance system, including the implementation, tracking, maintenance, and effectiveness checking of all PV quality system related activities. The incumbent will support the organization and maintenance of PV compliance activities with metrics.  Substantial focus will be placed on overseeing pharmacovigilance procedural deviations, CAPA, and change control management activities.  Additional support will be provided for ensuring compliance with Medical Safety and Labeling activities within Global Pharmacovigilance and Labeling.

Essential Functions

• Provide guidance in the development of corrective and preventative action (CAPA) and effective measures for PV related change controls, deviations, audits and inspections.  Where there is cross-reference and/or cross functionality with other functional controlled procedures, ensure alignment with PV regulatory requirements, industry best practices, and internal procedures
• Support the management of pharmacovigilance issues, deviations, CAPA development, and change control management
• Partner with the GPV&L sub-functions to enhance the ASR quality review process
• Perform quality review of ASRs and provide feedback to authors and leadership
• Collect, verify, and distribute metrics for monitoring compliance with signal management processes and timelines
• Support the development, implementation, and execution of Labeling quality and compliance KPIs/KQPIs
• Support (as determined by line management) PV process improvements including authoring/updating controlled procedures as it relates to compliance activities
• Perform quality review of assigned aggregate reports (PSUR, PADER, REMS Assessment Report, etc).  Maintain documentation and reports for compliance continuous improvement activities
• Assists with inspection related activities, (pre-, peri- and post-inspection)
• Remain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting PV, and develop strategies to support the patient safety at the local level

Required Knowledge, Skills, and Abilities

• Minimum 5 years business, pharmaceutical, or biotechnology industry experience
• Knowledge of Good Pharmacovigilance Practices (GVP) is required
• Can apply base level quality control technical concepts and skills
• Excellent written and verbal communications skills
• Ability to work in a fast-paced environment
• Individual contributor with oversight from line manager
• Ability to work in a team environment and support stakeholder
• Ability to work across geographical boundaries
• Disciplined, detail oriented, and good time management skills
• Ability to influence or gain acceptance from others in sensitive situations
• Self-directed and ability to take action as needed with limited oversight

Required/Preferred Education and Licenses

• Bachelor’s degree in business or life sciences required
• Lean Sigma certification, or equivalent certification, preferred but not required

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.

Please click here to apply.