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Careers At Incyte Corporation

Looking for a challenge and a chance to grow your career?

Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug candidates, our smaller size enables employees to see the direct impact of their contributions on the direction of the company. Due to our smart, agile culture and cutting-edge science, we delivered a novel, first-to-market product in an unmet medical need in 2011 - the first in the company's history.

Opportunities for taking on new and/or additional responsibilities, in addition to advancement, are a key element in our culture. Add to that a science-based, fast-paced work environment and you’ve got an exciting company in which to work.

In addition to opportunities for growth, we offer an outstanding benefits andcompensation package to help meet personal needs as well.

Take a look at our current openings to find the match that’s right for you!

Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer.


Drug Safety Associate

Department: Pharmacovigilance
Location: Incyte Corporate Headquarters

Drug Safety Associate 

Job Summary  (Primary function)
The 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 the case management lifecycle from receipt through case completion.  The position 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.

  • Assist with 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.

  • 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.

  • Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.

  • Maintain files and systems as appropriate.

  • Completion of additional tasks and projects as assigned by management.

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

  • Bachelorís degree in a science or healthcare related discipline (nursing/pharmacy preferred), or equivalent. 

  • Minimum of 2 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.

  • Experience using safety database systems (Argus experience preferred). 

  • Strong 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 work effectively within a team environment.

  • Solid organizational, time management, and problem-solving skills.

  • 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.

     

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