Local Person for Pharmacovigilance – Life Sciences - Mechelen

Our client is a consulting company that offers expertise in a portfolio of niche services that spans the entire lifecycle of a product. They offers expertise from clinical development to marketing authorization to post-launch activities that includes: biostatistics, regulatory affairs quality, market access, medical Writing and Pharmacovigilance. They facilitate interaction with health authorities.

The Local Person for Pharmacovigilance in Belgium is responsible for the establishment and maintenance of the marketing authorisation holder’s local pharmacovigilance system (in close cooperation with the client’s global PV system, EU-QPPV and the Deputy Local Person for Pharmacovigilance in the countries).

The Deputy takes over the responsibilities of the Local Person for Pharmacovigilance in case of absence.

Your role

As part of the Pharmacovigilance Team, located in the area of Mechelen, you will take the role for the Benelux region. You will be in charge of the management and investigation of adverse events. Your role also involves contact with the authorities for submissions, review of side effects, review of scientific literature, etc.

• Set up and manage the local pharmacovigilance system including:

Local Literature Search

Local ICSR Management

PV Intelligence Screening

Local PSMF Maintenance

Setting up local Organized Data Collection

Local PVA Management

Local adaptation and submission of PSUR / RMP

Local signal detection

Implementation of additional Risk Minimization Measures

Reviewing materials relating to local post-authorization safety

Integrated first Level Medical Information and PQC Support

• Maintain an up-to-date compliant national pharmacovigilance system
• Act as main contact point for the colleagues, as well as for client’s country specific questions
• Act as primary contact for PV for Competent Authority in the Territory
• Interface between the EU-QPPV / Global PV team at client and the local regulatory authority
• Provide 24/7 access to ensure business continuity and fulfilment of pharmacovigilance obligations
• Participate in PV-relevant audits and inspections
• Attend regular meetings according to project meeting schedule
• Provide monthly PV report on status of local PV system in the country/ies
• Ensure PV training of affiliate employees, service providers and Third Parties

You hold an University degree in Medicine, Pharmacy or Life Science

You have +4 years’ experience and profound knowledge in the field of pharmacovigilance

You have very good command of English and Dutch (mandatory). French is a plus.

You have a strong team spirit and you work in a collaborative way.

You have the sense of responsibility and a down-to-earth mentality

Our client offers a dynamic and ever evolving enterprise. You would have the chance to get involved in the company evolution.

Our client offers a full-time open-ended contract and good salary package and flexible advantages.