What are the responsibilities and job description for the Drug Safety Specialist, Pharmacovigilance position at The Fountain Group?
Drug Safety Specialist, Pharmacovigilance (Remote : Office in Cambridge, MA).
Details for the position are as follows :
Job Description :
- Participate in assigned clinical study team meetings to provide pharmacovigilance support.
- Liaison with DSPV Operations and other Blueprint teams (i.e. study teams) on execution of study deliverables (i.e. study start up, safety management plans, SAE reconciliation, query management, TMF), aggregate reporting and post marketing activities, as required.
- Participated in sponsor oversight of Adverse Event / Serious adverse event processing and reconciliations by outsourced vendors, including the review of Individual Case Safety Report processing (case triage, data entry, coding review, sponsor approval and narrative writing), as well as monitoring of Individual Case Safety Report reporting within the Company Sponsored Safety Database.
- Supports monitoring of Quality of vendor of Individual Case Safety Report processing for clinical and post marketing cases
- Support the monitoring and performing of notification and / or submissions for Individual Case Safety Reporting for Clinical Trial submission cross functionally (e.g. CRO, Partner, Clinical, and / or Regulatory) with DSPV Systems Team
- Support DSPV Compliance with monitoring reports (i.e. KPI) and other oversight activities and ensure the implementation of effective corrective and preventative action plans.
- Supports the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
- Supports the daily management and execution of Drug Safety and Pharmacovigilance operations cross functionally.
- Additional safety related duties assigned.
- Candidates must be open to traveling onsite to the Cambridge, MA office as needed
- Shift Schedule : Monday – Friday, 40hrs. / week
- Pay Rate : $60 – 70 / Hour
Qualifications :
Who We Are :
The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.
Browse our website below for additional information on our company.
The Fountain Group
We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”
Salary : $60 - $70
