We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Local Person for Pharmacovigilance (LPPV) in Belgium
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.
- 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 at PharmaLex, 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
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Very good command of English and Dutch
- Good command of French is a plus.
- University degree in Medicine, Pharmacy or Life Science
- +4 years’ experience and profound knowledge in the field of pharmacovigilance
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.