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.
Job Summary (Primary function)
This position will be responsible for leading processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials. The position will be responsible for oversight and leading case management lifecycle from receipt through case completion. The position will also be responsible to lead Pharmacovigilance teams and groups and liaise with relevant parties (intradepartmental, external service provider/vendor or business partners) for related Pharmacovigilance issues as required.
Essential Functions of the Job (Key responsibilities)
Lead processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for Incyte marketed products and clinical trials.
Support DSA teams within the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions.
Perform case processing (including case deactivations) and data gathering tasks within Argus Safety Database and other Incyte systems (i.e. EDC systems).
Lead literature review and article procurement as required.
Lead project start-up activities including safety reporting plan review, safety database configuration/updates, regulatory/submission impact analysis, training and tracking as applicable.
Lead and perform retrospective quality review and document findings, and contribute to metric compilation.
Lead business partner and other query management.
Represent Pharmacovigilance on project teams.
Provide in-depth technical expertise on Pharmacovigilance processes and systems.
Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
Lead Pharmacovigilance data reconciliation including databases and listings (post marketing and clinical trial sources) as required.
Train and mentor case processing staff.
Actively identify process improvement and efficiency needs and escalate as needed.
Create procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes.
Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
Maintain files and systems as appropriate.
Assist with resource management processes, including line management of assigned junior operational staff.
Completion of additional tasks and projects as assigned by management.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree in a science or healthcare related discipline (nursing/pharmacy preferred), or equivalent.
Minimum of 6 years pharmacovigilance experience or other equivalent clinical or pharmaceutical 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).
Ability to lead teams.
Advanced 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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