Pharmacovigilance Assistant (Prague)

  • Full-time
  • Department: ICSR Management

Company Description

PrimeVigilance, an Ergomed company, was established in 2008 by former Drug Regulators, to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO definition of pharmacovigilance). Since then, PrimeVigilance has added other services including medical information call centres, and has grown to become one of the global leaders in its field, providing services to over 150 client companies in more than 100 countries. We continue to expand as we strive to become the leading global pharmacovigilance and medical information service provider. Our Mission is a world with safer drugs.

PrimeVigilance is continuing to expand and is looking for a Pharmacovigilance (PV) Associate to join our dynamic and rapidly growing organization.

Job Description

The PV Assistant will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance clients.

  • Receipt, acknowledgment, tracking and filing of Individual Case Safety Reports (ICSRs) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
  • Providing administrative support to other activities undertaken by the project team on behalf of the client and the company, including but not limited to:
    • Tracking and filing ICSRs;
    • Receiving and returning safety messages and acknowledge receipt;
    • Carrying out Individual Case Safety Reports (ICSRs) local regulatory reporting;
    • Tracking periodic reports submission
  • Maintaining the archive
  • Preparing documents’ final lay out
  • Organising meetings and teleconferences
  • Assisting the organisation of PrimeVigilance offices
  • Performing other miscellaneous administrative tasks (e.g. daily and monthly evidence of work, maintenance of the employee register etc.)

Qualifications

  • Educated to at least High School level
  • Fluent command of English (written and oral)
  • Advanced knowledge of MS Office (Word, PowerPoint, Excel)
  • Excellent organizational and time management skills
  • Excellent communication skills
  • Self-motivating, able to assume responsibility and work autonomously in a professional manner

Additional Information

Our Offer

  • 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
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