Drug Safety Associate

Job Summary (Primary function)
This position 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.

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 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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You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).