PV assistant

PrimeVigilance • Raleigh, NC

2d

About The Position

PrimeVigilance (part of Ergomed Group) is a specialized pharmacovigilance service provider established in 2008. They have experienced global organic growth and have staff across Europe, North America, and Asia. Their services include Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-lasting relationships and establishing themselves as a global leader in their field. They cover all therapy areas, including medical devices. The company invests in its staff through an excellent training and development platform, valuing employee experience, well-being, and mental health. They recognize that a healthy work-life balance is crucial for employee satisfaction and fosters an environment for high-quality client service. The PV Assistant role supports the ICSR Management Unit in administrative tasks, tracking, storing, and planning, and may be involved in processing simple and standardized ICSRs after appropriate training.

Requirements

• High school or university graduate.
• Experience with administrative work; high level of organization skills
• English - advanced (spoken, written)
• Experience with MS Office Word, Excel

Nice To Haves

• Experience desirable, but not required in administrative position.
• Good communication skills

Responsibilities

• 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
• 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

• Career Level: Entry Level
• Education Level: High school or GED