Drug Safety Officer

Belgium - Life Sciences & Health Care - Pharmaceutical - Project Management & Services - Academic Bachelor

Brunel is looking for a Drug Safety Officer to assist and support the CSS Regulatory Affairs, Global Strategic Implementation Department with one of our clients in the Pharmaceutical industry.

Feel free to contact

Katrien Daneel, Account manager

Apply now

About this role

Main tasks:

  • Technical Dossier analysis of feedback provided to Notified Bodies and Questions received from Notified Bodies.
  • Assists and supports the team members in the execution of regulatory strategies impacting all CSS for MDR Implementation and Execution.
  • Gathers and assembles data necessary for the development of the regulatory aspects of project plans including tracking, planning and communication.
  • Assists in the execution of regulatory strategies for non-EU countries, including coordinating and tracking document requests.
  • Creates and approves ECO’s pertaining to the Coordinator’s projects and duties.
  • Responsible for administrative tasks to support the CSS MDR activities including preparation of meetings and general administrative activities.
  • Responsible for compiling reports, presentations and creating flowcharts.
  • Researches, collects, cross-check data from different sources, and responds to requests from internal colleagues.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

About you

  • You are in possession of a university, bachelor’s degree or equivalent.
  • You have 0-2 years of work experience, preferably but not limited to regulatory affairs (Technical File/Design Dossier/Technical Dossier preparations or submissions).
  • You have a good command of database and spreadsheet software.
  • You have excellent written and verbal communication skills in English.
  • You are creative and have advanced computer skills: Excel (mandatory), Power Point, One Note, Microsoft Team.
  • You are analytical, self-motivated, energetic, well organized, and a self-disciplined person.
  • You pay attention to detail and have the capacity to work autonomously.
  • You have the ability to take on diverse tasks.

What we offer

Our network and expertise make it possible for us to advance your career. Brunel has a reputation of working with some of the best in the business. That's what we continually strive for. Over 40 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Publication: PUB319552
  • Location: Belgium
  • Market: Life Sciences & Health Care
  • Hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of expertise: Project Management & Services
  • Closing date: Wednesday, September 29, 2021
Apply now

Feel free to contact

KD

Katrien Daneel

Account manager Brunel Belgium Mechelen

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