Manager, Global Risk & Safety

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Summary (Primary function)
The Manager, Global Portfolio Safety Management (GPSM) will be responsible for overseeing Global Pharmacovigilance (PhV) programs and other safety related data for Incyte marketed products and Incyte pipeline clinical trials, IST/IIRs, post-marketing programs and reporting requirements. This role will also be responsible to support GPSM Project Leads and other GPSM staff and streamline collaboration with Development Operations, Data Management, Regulatory Affairs, Medical Affairs and other Incyte departments as applicable, assisting with coordinating PhV responses for all Incyte compounds and products.

Essential Functions of the Job (Key responsibilities)

• Ensure compliance with internal procedures, regulatory requirements, and business partner agreements to ensure inspection readiness at all times.
• Lead strategic GPSM project(s) and actively support GPSM Project Leads with their assigned projects, ensuring an inclusive and collaborative approach that values diverse perspectives.
• Help to develop procedures (e.g. SOPs, Working Instructions, Job Aids), forms and templates, in support of efficient Project Management processes.
• Identify process improvements, efficiency needs and develop solutions as appropriate.
• Train and mentor GPSM staff members at various levels, as appropriate.
• Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources), as required.
• Act as Subject Matter Expert (SME) with Business partners, PhV service providers and other CROs.
  Facilitate GPRM cross-department training and brainstorming sessions for new programs and/or new products. Actively assist in developing new Business Partner Agreements (PVA).
• Coordinate GPRM efforts for new NDA/MAA regulatory tasks, as required.
• Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
• Departmental support for Portfolio overview, including during Audits and Inspections.
• Provide in-depth technical experience on Pharmacovigilance general processes and systems.
• Support GRMSS, GPRM Senior Management and the EU-QPPV as required.
• Provide functional GPRM oversight over Clinical trial and Post-marketing Pharmacovigilance processes.

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

• Discover - Develop - Deliver - Collaborate
• Minimum of relevant project management experience or equivalent relevant experience, with a focus on skills and competencies rather than specific years.
• Minimum of relevant Pharmacovigilance experience or equivalent clinical or pharmaceutical experience, with demonstrated leadership or management capabilities.
• Bachelor's degree in a Science or Healthcare related discipline, or equivalent experience.
• Travel (domestic and international) 10%.
• Proficiency in written and verbal English, or a willingness to learn, is preferred.
• Strong communication skills, both verbal and written, are essential.
• Ability to create and deliver presentations, with or without reasonable accommodations.
• Advanced organizational, time management, and problem-solving skills.
• Excellent ability to work effectively within a team environment.
• Proficiency in commonly used software applications (e.g., Microsoft Word, Excel, Outlook, and PowerPoint) is preferred.
• Advanced knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
• Proficiency using safety database systems (experience with Argus or similar systems is beneficial).

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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