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Pošalji prijatelju

Pharmacovigilance (PV) Safety Reporting Assistant (m/f)

Zagreb

Rok prijave:

We are an international fast growing healthcare company and as a result of our rapid growth we are looking for:

Pharmacovigilance (PV) Safety Reporting Assistant

PrimeVigilance is continuing to expand and is looking for a Pharmacovigilance (PV) Safety Reporting Assistant to join our dynamic and rapidly expanding organization.

Based in our offices in Zagreb (Croatia), the PV Safety Reporting Assistant will be responsible to ensure that the Safety Reporting and Exchange with Client partner’s activities are managed in a cost efficient manner of the highest quality and in compliance with global regulations and company policies and in accordance with any PV agreement.

Key Accountabilities:

  • Report of Individual Case Safety Reports (ICSRs) and Aggregate reports to Regulatory Authorities, Eudravigilance, Ethics Committees (EC)/Institutional Review Boards (IRB) and Investigators, as appropriate
  • Perform electronic reporting to National Competent Authorities via EudraVigilance (EV) Web Trader and/or Food and Drug Administration Adverse Event Reporting System (FAERS)
  • Perform ICSR submission reconciliation with clients or client’s partners, if required
  • Perform quality check of submission packages for all ICSRs and Aggregate reports submissions to Regulatory Authorities, Investigators and Ethics Committees/IRBs and packages prepared for exchange with clients or client’s partners, as appropriate
  • Maintain the Submission archive (in electronic version)
  • Perform daily download of ICSRs from the EudraVigilance
  • Provide support to PV Safety Reporting Associate, PV Regulatory Associate, Senior PV Regulatory Associate, PV Regulatory Manager and PrimeVigilance Senior Management

Qualifications and Skills:

  • 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

Our offer:

  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast growing healthcare company

If you would like to be considered for this opportunity, please send your application via
application link enclosing your English CV and Cover Letter.

Due to high a volume of applications only short-listed candidates will be contacted.

Deadline for applications: 26.01.2018.

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