at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
The Director, Pharmacovigilance Operations will be responsible for leadership of the global Pharmacovigilance teams responsible for pharmacovigilance activities in support of Incyte marketed products and clinical trials. The position will be responsible for ensuring compliance with operational procedures and regulations for all Pharmacovigilance functions (post-marketing and clinical trials). The Director will also provide support to the QPPV, as well as provide key direction with relationships with intradepartmental teams, external service providers/vendors and business partners.
Essential Functions of the Job
* Direct global Pharmacovigilance case processing and regulatory submission teams supporting Incyte marketed products and clinical trials to ensure quality and compliance with global regulatory timelines.
* Direction of Pharmacovigilance operational teams to support aggregate reporting and risk management teams.
* Direct quality and compliance support activities to ensure high quality and compliance of operational activities.
* Support the QPPV as required.
* Provide expertise on Pharmacovigilance processes and systems.
* Support Pharmacovigilance systems team with Operational leadership to ensure operational and submission technical requirements and workflows are met.
* Oversee Pharmacovigilance CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
* Support audit and inspection processes as required, including serving as functional subject matter expert as required.
* Assist to ensure inspection readiness at all times.
* Direct process improvement activities to ensure efficient operations.
* Ensure development of procedures (SOPs, Job Aids), forms and templates are completed in support of efficient case management processes.
* Direct resource management processes for global Pharmacovigilance Operations organization, including identification of staffing needs, recruitment of staff, line management, and succession planning.
* Develop managerial staff in assigned functional Pharmacovigilance processes, project and team management, and encourage growth by provision of regular mentoring and performance feedback.
* Direct and ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
* Oversight and direction of additional tasks and projects as assigned by senior management.
* Assist with Pharmacovigilance Operations budget development and oversight including resource management.
* Bachelor's degree in a science or healthcare related discipline (nursing/pharmacy preferred), or equivalent.
* Minimum of 10 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience, with an additional 8 years' management experience.
* Safety database system proficiency (Argus required).
* Expert knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
* Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
* Demonstrates accountability and responsibility for global team.
* Demonstrates leadership and mentorship ability.
* Expert project and staff management skills.
* Expert organizational, prioritization, time management, and problem-solving skills.
* Expert ability 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... For full info follow application link.
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