Senior Manager, GPhV, Pharmacovigilance Submissions - Incyte Corporation

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.

Job Summary  (Primary function)
The Senior Manager, Pharmacovigilance Submissions is responsible for the management of global ICSR submissions activities to ensure compliance with Incyte, global Regulatory Authority and Business Partner requirements.  The Senior Manager will ensure that the ICSR data elements transmitted to regulatory authorities meets global reporting requirements and company standards.  The position will be responsible for ensuring compliance with operational procedures and regulations for all submission functions.  The role will also be responsible to provide management and guidance of activities including: support of the QPPV, support oversight of external submissions vendors, and assist with strategic input on submission organizational support.  Also responsible for maintaining relationships with intradepartmental teams, external service providers/vendors and business partners.

Essential Functions of the Job  (Key responsibilities)

• Manage submission teams and oversee submission of required global ICSR reports for Incyte marketed products and clinical trials.
• Oversee the tracking and submission acknowledgement processing including submissions failure notifications to ensure timely resolution of issues.
• Participate in safety system configurations to ensure new project submission requirements and regulatory requirement changes are implemented by the operational and submissions teams as appropriate.
• Participate in regulatory intelligence gathering and management.
• Support the QPPV and Senior Management as required.
• Represent Pharmacovigilance Submissions on intradepartmental, business partners, and vendor teams.
• Provide in-depth technical expertise on global Pharmacovigilance submission processes and systems.
• Oversee CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes including root cause analysis for submission issues.
• Lead business continuity planning around global Pharmacovigilance submission processes.
• Support audit and inspection processes as required.
• Actively identify process improvement and efficiency needs and develop solutions as appropriate.
• Develop procedures (SOPs, Job Aids), forms and templates in support of efficient case submissions processes.
• Complete resource management processes, including line management of assigned staff and succession planning.
• Assist vendor manager with oversight of submissions vendor.
• 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.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor’s degree in a science or healthcare related discipline, or equivalent.
• Minimum of 8 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience, with an additional 2 years’ experience leading teams and 4 years submissions experience.
• Safety database system expert (Argus required).
• Advanced 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 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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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