Drug Safety Officer

PUB319552

About this role:

About this role:

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.

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.

What you need to bring:

What you need to bring:

  • 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.

Benefits:

Benefits:

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.

Start applying immediately

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Katrien Daneel is happy to clarify anything about this vacancy. When reaching out, use this number:
PUB319552

Account manager

Katrien Daneel
Brunel Belgium Mechelen
k.daneel@brunel.net

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