Medical Safety Writer in Mechelen

At SGS, you can choose. First of all, out of our various vacancies. However, SGS also gives you another choice. Do you choose to expand or to enrich? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business. SGS is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to more than 90 000 colleagues worldwide, with 1650 employees in Belgium only. Our employees give 110% of themselves every day, divi

Beschrijving

The Medical Safety team is responsible for the collection and management of adverse effects and safety information of medicinal products used in clinical trials or available on the market to patients. In view of these responsibilities, we are looking for a Safety Writer who will write regulatory and medical reports based on these collected data.

Your main task is to ensure proper creation of following documents:

  • Periodic Adverse Drug Experience Report (PADER)
  • Development Safety Update Reports (DSUR); Periodic Safety Update Reports (PSUR)
  • Epidemiology reports
  • Clinical Summaries and Clinical Overviews
  • Safety Signal Reports
  • Writing parts of / updating / compiling Investigator’s Brochures (IB)

What do you need to become a Medical Safety Writer ?!

  • A scientific education (Master / PhD)
  • Experience is a major plus
  • Ability to synthesize, analyze and summarize large amounts of complex data
  • Good communication skills
  • English: fluently written and spoken!
  • Stress-resistant
  • Very good knowledge of Word
  • Respecting budgets and timelines

Extra informatie

Status
Open
Opleidingsniveaus
HBO5
Plaats
Mechelen
Dienstverbanden
Fulltime (startersfunctie)
Gepubliceerd op
28-11-2024
Beroepsgroepen subcategorie
Administratief
Rijbewijs nodig?
Nee
Auto nodig?
Nee
Motivatiebrief verplicht?
Nee
Talen
Arabisch

Mechelen | Administratieve vacatures | Fulltime (startersfunctie) | HBO5

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