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)
The Senior Drug Safety Associate will be responsible for 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 leading case management lifecycle from receipt through case completion. The role will also be responsible to liaise with relevant parties (intradepartmental, external service provider/vendor or business partners) for related case processing tasks as required.
Essential Functions of the Job (Key responsibilities)
Perform 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.
Completion of 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).
Assist with 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.
Perform retrospective quality review and document findings, and contribute to metric compilation
Assist with business partner and other query management.
Represent Pharmacovigilance on project teams.
Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required.
Train and mentor case processing staff.
Assist with creating 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.
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 4 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
Proficiency using safety database systems (Argus experience preferred).
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).
Excellent ability to work effectively within a team environment.
Advanced organizational, time management, and problem-solving skills.
Ability to create and deliver presentations.
Excellent verbal and written communication skills.
Fluency in written and verbal English.
Travel (domestic and global) 10%.
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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