Advice & reporting for the chemical and pharmaceutical industries

Senior Drug Safety Officer

Deadline for applications: 
Saturday, 5 May, 2018
Job description: 

For our offices in Mechelen (Belgium) and on occasion in the offices of our clients in the Brussels - Antwerp region:

Conduct pharmacovigilance, materiovigilance and cosmetovigilance in compliance with the current EU and national (Benelux) legislation:

  • Handling of post-marketing cases in clients’ local databases in compliance with client’s and Archemin’s procedures and applicable regulations.
  • Administrative tasks (archiving of the documents, reporting…).
  • Follow-up of safety information including communication with the global pharmacovigilance department, and with the local reporters in Benelux and France.
  • Screen scientific literature and generate weekly reports
  • Translation to English of information from cases from Benelux and France (NL, FR).
  • Conduct monthly reconciliation activities including pharmacovigilance signal detection and quality control of database entries
  • Assist in the compilation of Periodic Safety Update Reports (PSUR), Reports on Signal Detection and Validation as well as Risk Management Plans (RMPs)
  • Maintenance of Pharmacovigilance System Master Files (PSMF) and eXtended Medicinal Product Dictionary on behalf of the Customers
  • Participate in the development and maintenance of the Archemin Pharmacovigilance quality system
  • Contribute to the 24h/24h permanence

Reports to the Operations Manager.

  • Preferably a Degree in life sciences
  • Minimum 3 years of experience in a comparable function: being familiar with the field's concepts, practices and procedures and knowledge of a pharmacovigilance software (Eudravigilance, Safety databases).
  • Focused on detail, meticulous, respectful of the deadlines, high commitment.
  • Outstanding interpersonal and communication (written and verbal) skills are required: the ideal candidate is trilingual (Dutch / French / English) CEFR level B1 or higher.
  • Able to cope with a broad range of projects, high stress levels and time pressure.
  • Diplomatic and flexible personality, proactive, autonomous.
  • Proficient with computer and standard software programs (Excel, Word, Outlook).
  • Only candidates living in Belgium will be considered, candidates living in the area Antwerp – Brussels – Leuven have an advantage.
We offer: 
  • An environment where autonomy and entrepreneurship are stimulated.
  • The chance to participate in projects that influence the company strategy over the coming years International context.
  • Salary dependent on relevant experience + extra-legal benefits.
  • A full-time function is offered
  • Applications + a detailed cv should be sent in Word format to hr [at] before the expiry date.
  • All applicants will receive a reply.
  • The procedure will involve one or more face-to-face interviews