Pharmacovigilance Operations Compliance Manager

Summary
The Pharmacovigilance Operations Compliance Manager is responsible for managing the development and execution of compliance monitoring systems within Pharmacovigilance Operations to ensure compliance with global regulations, partner agreements, and Incyte policies and procedures. The position will oversee the Pharmacovigilance Corrective Action and Preventative Action (CAPA) investigations as well as Root Cause Analysis activities to support continuous quality improvement. The Manager will be responsible to assist with Health Authority Communications as applicable, and also assist with audit and inspection oversight activities as requested. The role will also be responsible to liaise with relevant parties (intradepartmental, external service provider/vendor or business partners) for related tasks as required.

**Responsibilities**:

- Manage the development and maintenance quality compliance monitoring and documentation systems for Pharmacovigilance Operations relative to individual case safety repots (ICSRs), scheduled aggregate periodic reports, and ad hoc responses to authorities.
- Oversee completion of detailed Root Cause Analysis (RCA) of non-compliance, and provide input for quality improvements.
- Oversee Corrective Action and/or Preventative Action (CAPA) investigations for identified quality issues, and ensure timely resolution for identified findings.
- Oversee process, tools and tracking mechanism for Incyte Pharmacovigilance deviations, CAPAs and RCA.
- Develop and maintain monthly Compliance Management Report.
- Ensure accurate and up to date tracking of compliance data and metrics.
- Identifies quality and compliance issues, provide solution and improvement methods, and escalate as appropriate.
- Identify, review, and ensure dissemination of global regulatory intelligence impacting Pharmacovigilance operational activities to ensure compliance with latest regulatory guidelines at all times.
- Support responses to Health Authority requests.
- Assist to oversee Pharmacovigilance audit processes and inspections as needed.
- Provide information and updates to the Pharmacovigilance System Master File as applicable.
- Lead global compliance meetings.
- Provide in-depth technical expertise on Pharmacovigilance quality and compliance processes.
- Represent Pharmacovigilance operational quality and compliance on intradepartmental, business partner, and vendor teams.
- Develop procedures (SOPs, Job Aids), forms and templates in support of Pharmacovigilance operations quality and compliance processes.
- Train and mentor staff in compliance related function.
- Assist in resource management processes, including line management of assigned staff and succession planning.
- Develop supporting staff skills, encourage growth and provide regular performance feedback.
- Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
- Maintain files and systems as appropriate.

**Requirements**:

- Bachelor’s degree in a science or healthcare related discipline, or equivalent.
- Minimum of 6 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience with an additional 1-2 years of leading teams.
- Minimum of 5 years quality and compliance experience.
- Advanced proficiency with quality investigation process (i.e. CAPA and RCA processes).
- Proficiency with audit and inspection processes.
- Experience using safety database systems preferred.
- Advanced knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices, with emphasis on reporting rules and timelines.
- Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
- Demonstrated accountability and responsibility for both management role and assigned team.
- Expert organizational, time management, and problem-solving skills.
- Proficiency with creating and delivering presentations.
- Excellent verbal and written communication skills.
- Fluency in written and verbal English.
- Travel (domestic and global) 10%.
- Ability to travel to office for monthly departmental meetings at assigned Incyte offices as well as for ad hoc meetings and/or urgent matters (notice period: 24 hours or less) as needed.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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