Pharmacovigilance (PV) Services Associate

Location: Belgrade, SRB

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

PV Services Associate has primary responsibility to ensure that the Literature Screening responsibilities and 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 Pharmacovigilance (PV) agreement. The role is ideal for a confident and enthusiastic individual who has an interest to build on their knowledge of PV.

PV Services Associate has a position responsible to ensure that all contracted Literature Screening responsibilities and activities are managed in compliance with regulations and company policies and in accordance with any PV agreement.

Key Accountabilities
  • To assist with the development of literature search strategy
  • To participate in weekly and ad hoc literature searches
  • To participate in weekly and ad hoc literature screening activities to identify potential
  • Individual Case Summary Reports (ICSRs) and other relevant safety related information pertaining to nominated products
  • To assist with ordering copies of full literature articles for review
  • To maintain a record and track all literature abstracts screened and full literature article reviewed, with actions taken and the reason
  • To forward any ICSRs to PV Associates for data entry into the global drug safety database
  • File other relevant safety related information for use in signal detection and Periodic Safety Update Reports;
  • To participate in the screening of local non-indexed literature as required
  • Accessing EV on daily basis and downloading Medical Literature Monitoring (MLM) search and MLM ICSR results (excel spreadsheets)
  • Tracking all the MLM search results, MLM ICSRs list downloads and exported ICSRs
  • Uploading the MLM search results and the list of ICSRs in the designated PrimeVigilance Portal area
  • Reviewing the list of ICSRs daily
  • Checking all urgent/immediate issues have been addressed in a timely manner
  • Keeping the European Medicines Agency (EMA) MLM Literature Screening Tracker up to date with the latest information received from the EMA
  • Providing regular updates regarding workload, project status and metrics concerning enquiries to the PV Services Manager
  • To assist with the development and improvement of literature screening processes and procedures
  • To assist with departmental regulatory inspection preparedness for the company pharmacovigilance system in the European Union and actively participating in PV inspections or audits
  • To assist with writing of procedures for literature screening processes and procedures

Qualifications and Skills
  • University degree in Biomedical sciences or Natural sciences
  • Advanced knowledge of English
  • Advanced knowledge of MS Word and Excel
  • Excellent attention to detail and organizational skills
  • Independent problem solving and decision-making skills
  • Process oriented and critical thinking
  • Responsible approach to work duties

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

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

You can download and view our Candidate Privacy Policy here.

Thank you for your application. Unfortunately, because of the volume of applications we receive, we are not able to give status updates, but if you are invited for an interview, we will contact you directly.

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