Sr. Drug Safety Specialist (Pharmacovigilance)
Location: Boston, MA
Experience: 3 or more years
Job Summary: Senior Drug Safety Specialist
The Senior Drug Safety Specialist is responsible reporting and processing all ICSRs related to marked and investigational products. They are responsible for supporting the management and assessment of PV data and safety reports, as well as assisting with process development. Lastly they would work with study sites, vendors, and HCPs as needed.
- Complete case processing goals such as data entry, event extraction, triage, and selecting the necessary coding
- Execute a preliminary case assessment to determine the expectations of the case based on the medical context, and confirm the case meets necessary criteria for events of special interest
- Review ICSR information and source documents to ensure completeness, consistency, and accuracy. Execute QC on cases obtained by other members of your team
- Investigate missing case information and perform follow-up requests until their necessary completion. Ensure the documentation of all queries
- Have knowledge of regulatory requirements and complete adverse event reports within regulation of company SOPs, FDA, ICH, EMA, and SDEA time frames
- Help with the review and preparation of ICSRs, and safety summaries/reports
- Work collaboratively with external and internal partners, such as PV physicians
- Assists with the development of work instructions, forms, SOPs, conventions, or other internal documents. Be prepared to perform any other tasks that may be asked of you.
- Bachelor's Degree in pharmacy, life sciences or other applicable science
- A minimum of 3 years experience working in PV or Drug Safety
- Knowledge of ARGUS or ARISg databases
- Knowledge of coding and applications of WhoDrug and MedDRA
Sthree US is acting as an Employment Business in relation to this vacancy.