Manager, Global Risk Management & Safety Surveillance Portfolio Management
Overview
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.
The job is based in Wilmington Delaware, US.
Job Summary (Primary function)
The Global Risk Management and Safety Surveillance (GRMSS) Portfolio Manager is responsible for covering Pharmacovigilance (PhV) activities throughout Incyte products lifecycle management (other than Case management) for complete set-up, maintenance and closeout of Incyte programs. The position is responsible for ensuring global PhV oversight on Incyte pipeline trials, IST/IIRs, post-marketing programs and reporting requirements. The role is also responsible to streamline and standardize 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)
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- Lead all PhV Project start-up, maintenance and closeout activities, including, but not limited to, Safety Reporting Plan review, safety database configuration/updates, regulatory submission impact analysis, training, as applicable, for clinical trials, IST/IIRs and post-marketing programs.
- Serve as the primary Global Pharmacovigilance & Risk Management (GPRM) liaison for key Incyte functions (e.g., Development Operations, Medical Affairs, Data Management, Regulatory Affairs, and Commercial).
- Departmental support for Portfolio oversight, including during Audits and Inspections.
- Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
- Coordinate GPRM efforts for new NDA/MAA/Product filing regulatory tasks, using the relevant checklist, as required.
- Organize GPRM cross-department training and brainstorming sessions for new programs and/or new products. Train other GRMSS/GPRM staff, as appropriate.
- Act as Subject Matter Expert (SME) with Business partners, PhV service providers and other Contract Research Organizations (CROs).
- Coordinate the development and maintenance of the global literature search strategy for assigned product(s), per Incyte procedures.
- Contribute to the preparation and revision of INCY Periodic Safety Reports, as applicable.
- Facilitate interactions with Clinical CROs at study and product levels and ensure accuracy of the safety elements part of the contracts/agreements with these CROs.
- Assist with creating procedures (e.g. SOPs, Working Instructions, Job Aids), forms and templates, in support of efficient Project Management processes.
- Ensure compliance with internal procedures, regulatory requirements, and business partner agreements to ensure inspection readiness.
- Other duties as assigned.
Qualifications (Minimal acceptable level of education, work experience, and competency)
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- Advanced degree (such as Masters) in science or healthcare related discipline, or a combination of relevant education and experience.
- Pharmacovigilance or other equivalent clinical experience, generally with a minimum of 6 years’ experience.
- Project Management experience or equivalent relevant experience, generally with a minimum of 2 years’ experience.
- Experience in using safety database systems (Argus experience preferred).
- Good 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).
- Demonstrated ability to work effectively within a team environment.
- Excellent verbal and written communication skills, both verbal and written, with ability to create and deliver presentations in an effective manner to a range of audiences.
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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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