Pharmacovigilance / Drug Safety Professionals (Juniors and Experts)

We are continuously looking for experienced pharmacovigilance professionals to reinforce our Valesta team.

  • You are fluent in English?
  • You have experience with safety and regulatory data?
  • You are meticulous, value the safety of patients and conscientious?

Then you might be the Pharmacovigilance professional we are looking for!

Responsibilities 
  • Reviewing, assessing and processing safety data for phase I, II & III clinical trials and marketed products
  • Maintaining information about all SAEs/ADRs in a secure location, in accordance with local regulations
  • Tracking of regulatory guidelines and directives related to Medical Affairs department activities
  • Maintaining a ‘list of Authorities and other official bodies’ to whom SAEs/ADRs should be reported, as well as corresponding reporting procedures
  • Review of listings, concomitant therapy, line listings, clinical trial protocols, …
  • Report writing: narratives, DSURs, PSURs, product related expert reports, ISSs, Clinical Expert Statements/Clinical overviews for registration reneweal purpose, involvement in writing of the safety section of the IB, SDEA, SPP,…
  • Direct reports, backup and internal/external communication
Profile 
  • You are a Medical doctor, Pharmacist, PhD or equivalent by experience
  • Experience within pharmacovigilance is preferred
  • You are fluent in English, knowledge of French or Dutch is an asset
  • You have excellent organisational skills
  • You show strong planning skills and easily respect timelines
  • You are a flexible team player, highly rating confidentiality
  • You are very punctual and accurate in your work
Contact Information 

Claire Aerts
+32 15 21 11 04
claire.aerts@valesta.com

Application form : Pharmacovigilance / Drug Safety Professionals (Juniors and Experts)

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