Drug Safety Associate - temporary assigment, 5 months
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.
Duties and 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.
- 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.