DRUG / PRODUCT SAFETY OFFICER

BeerseIPharmaceutical Sector

Job description

For one of our clients in BEERSE we are looking for a DRUG / PRODUCT SAFETY OFFICER

As a DRUG / PRODUCT SAFETY OFFICER you will have the following responsibilities:

  • filing documented data an narratives regarding adverse events
  • organizing and updating regulatory requirements applicable to drug and product safety reporting. 
  • Revising standard procedures regarding drug safety as directed. 
  • Generating reports, executing database queries and creating ad hoc reports as requested.
  • Recording and tracking event reports submitted to regulatory agencies.
  • Updating files with information obtained from health professionals and consumers regarding possible adverse events. 
  • Tracking submissions of cumulative safety data to regulatory agencies.
  • Maintaining files concerning potential adverse events which do not meet criteria for entry into database. 
  • Maintaining training files for staff as well as wider safety reporting training 
Profile
  • You have a Master's or Bachelor' s degree (or equivalent by experience). 
  • You have at least 2 years of work experience, preferably but not limited to regulatory affairs
  • You are fluent in English and Dutch
  • You are able to work on multiple simultaneous tasks with limited supervision.
  • You are a quick learner. 
  • You are quickly available. 
  • You have excellent customer service skills, and team collaboration skills.
Organisation and department description

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis.

Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Offer

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible.

We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Any questions?
Bénédicte Joret Technical Projectsourcing Select Projects +32 3 203 50 88
DRUG / PRODUCT SAFETY OFFICER Vacancy information
78401
Life Science
Project Sourcing
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