PV assistant

Ergomed • Raleigh, NC

12h

About The Position

Summary
· Assures and exerts activities leading to effective work in the area of ICSR Management
· Supports the ICSR Management Unit in administrative tasks, tracking, storing, planning
· May be involved in processing of simple and standardised form ICSRs, following appropriate
training
Roles and Responsibilities:
Receiving and returning safety messages and acknowledge receipt, tracking and filing of
Individual Case Safety Reports (ICSRs) and/or requests for followup in compliance with applicable regulations, PrimeVigilance
procedures and in accordance with client specific requirements and timelines
· Perform other miscellaneous administrative tasks, as applicable
· Performing activities in the scope of ICSR management unit within agreed extent and timeframe
(including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) that require simple processing (e.g.
solicited cases with limited information, minimal information reports, E2B cases without
narrative writing, data clean-up activities and standardised form reports) from all
sources in compliance with applicable regulations, PrimeVigilance procedures and in
accordance with client specific requirements and timelines

Requirements

• High school or university graduate.
• Experience desirable, but not required in administrative position.
• Good communication skills
• Experience with administrative work; high level of organization skills
• English - advanced (spoken, written)
• Experience with MS Office Word, Excel

Responsibilities

• Receiving and returning safety messages and acknowledge receipt, tracking and filing of Individual Case Safety Reports (ICSRs) and/or requests for followup in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
• Perform other miscellaneous administrative tasks, as applicable
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to): • Processing Individual Case Safety Reports (ICSRs) that require simple processing (e.g. solicited cases with limited information, minimal information reports, E2B cases without narrative writing, data clean-up activities and standardised form reports) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines

Benefits

• Competitive salary
• Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 501-1,000 employees