Specialists in Pharma, Clinical & IT Recruitment

Pharmacovigilance Officer

Reference:
VAC-31
Job Type(s):
PVG / Drug Safety
Salary:
Salary negotiable
Town/City:
Near Brussels
Contract Type:
Permanent
Date Posted:
12/12/2012 08:50:00
Start Date:
07/01/2013
End Date:
01/03/2013

Description

My client a global bio-pharmaceutical company focused on developing and commercializing innovative medicines they are looking for a Pharmacovigilance Officer to join their team near Brussels.

The Role:

The company is searching for a Pharmacovigilance Officer to support the pharmacovigilance operations currently limited to safety in clinical development, later to be extended to post-authorisation pharmacovigilance.
The candidate (m/f) will report to the Head of Pharmacovigilance Operations.

  • Evaluation and QC review of draft SAE reports.
  • Monitoring compliance of regulatory reports: SUSAR, ASRs and 6-monthly line listing including distribution lists and timelines.
  • Active management of pharmacovigilance service provider
  • Prepare, review and/or contribute to PV and safety containing documents (protocols, FSR, IBs, periodic safety reports, DDPS, RMPs, CCSI, etc.)
  • Maintain the service provider updated on the relevant documents needed to perform the contracted activities (IBs, protocols, lists of participating centres, etc.)
  • Assistance with SAE reconciliation.
  • Act as main contact liaison between the PV service provider, the CRO, TG project managers, medical and other functions as necessary.
  • Maintenance of TG Safety archive, which include: vendor contracts, project safety plan, SAE forms and instructions, Regulatory documentation: ASR, 6-Month line listings, SUSARs, Regulatory requirements, SAE listings for each project, ARGUS Documentation and Eudravigilance documentation
  • Prepare and review SOPs.
  • Other PV related activities as requested by line manager.

 

The Requirements:

  • You have a degree in a biological science with at least 4 years (bio)pharmaceutical experience in pre- and post-authorisation pharmacovigilance including writing of PV reports(PSURs,DSURs) knowledge of pharmacovigilance regulations and guidelines.
  • You are familiar with Quality aspects related to PV.
  • You are fluent in English, both verbal and written (capable of writing clearly and accurately). Knowledge of other languages will be a plus.
  • You show initiative, proactiveness and a quality-driven approach to work, and team spirit.
  • You have good interpersonal, communication and organization skills.
  • You are PC literate; knowledge of any PV software system (ARGUS, ARISg) would be an advantage. 

Please contact Emma Hobbs on +44 1483 397070 emma@arc-7.com to discuss this position in more detail.

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