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.
- 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] archemin.eu before the expiry date.
- All applicants will receive a reply.
- The procedure will involve one or more face-to-face interviews