A global pharmaceutical company is advertising a vacancy for a Qualified Person/QPPV in their office in Belgium. The organisation supports the global life sciences industry across the product development and marketing life cycle by transforming the way organisations capture, monitor, manage, and use information. This is an exciting opportunity to work with a leading organisation that provides expertise in regulatory transformation and pharmacovigilance.
- Managing adverse events (AE) with a contract partner.
- Overseeing QC of these case reports.
- Carrying out QC of follow-up of these case reports, including QC of translation.
- Reconciling with local QA and MedInfo.
- Requesting translations of Eudravigilance downloaded cases by Accenture; usually only a few sentences and the frequency is low (usually once or twice a week).
- Reviewing SmPC in TaaS (platform) and comparing this with an English version.
- Reviewing abbreviated PI in Dutch, French, and German at a rate of once every 4 months.
- Answering the emails of HA, HCP, or patients in their local language; this happens than less than once per quarter.
Skills and Requirements:
- A degree in Life Sciences, MD, or pharmacology.
- Experience: 5- 7 years minimum of experience in Pharmacovigilance and European QPPV.
- Excellent knowledge of PV regulations and guidelines (GVP).
- Resident in EU.
- Experience and knowledge of local QPPV responsibilities.
- Knowledge in medical writing/reviewing aggregate reports and RMP, signal detection management.
- Fluency in Dutch, French, and German for the review of documents.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.