(Junior) Pharmacovigilance & Materiovigilance Officer
+32 494 04 21 32
PV Coverage Processes
- Qualify PV coverage and processes for back-up coverage (including coverage outside of business hours).
- Organize PV training of the Affiliate staff.
- Guarantee PV business continuity planning and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.
Regulations & Compliance
- Manage prompt and direct notification of GPV / QPPV of defined items and changes in local pharmacovigilance regulations (e.g. pharmacovigilance inspections, requests to provide PSMF, DHPC requests, guidelines/ circulars on PV tasks (eg RMA …).
- Monitor affiliate PV system performance and compliance, and preventing/resolving of nonconformities (CAPA plan)/ deviations.
- Handle internal PV audits and inspections from regulatory authorities. Affiliate Individual Case Safety Report (ICSR) management (that is, receipt, documentation, forwarding to GPV, tracking, expedited reporting, etc.).
Data Collection & Report
- Collect safety data and other PV-related responsibilities in relation to interventional studies (clinical trials).
- Collection of safety data and other PV-related responsibilities in relation to organized data collection schemes (that is, non-interventional studies, registries, patient support programs, market research programs, etc.).
- Local screening of scientific literature and social media for safety information
- Keep up-to-date records of the organization and personnel of the local product safety group (LPSG) or local medical/PV team
- Ensure periodic safety reporting (in collaboration with EPD GPV regarding scheduling, local submissions, etc.)
- Handle inquiries relating to product safety including regulatory authority inquiries. Handle safety information arising from e.g. product complaints, medical information inquiries.
Risk Management Plans & Safety Data Exchange Agreements
- If applicable, execute local implementation and tracking of RMP activities resulting from global RMPs.
- Contribute to product labelling changes (review of product information).
- Consideration of PV matters during locally performed due diligence activities and locally negotiated contractual agreements, and exchange of safety information as defined in safety data exchange agreements.
- All ICSR information received originally at the affiliate should be archived locally. Propose / create and review local SOP’s (if necessary). Affiliate local procedures must be reviewed and approved by relevant functions. Guarantee an availability 24h/24h, 7d/7d.
- Master degree in Pharmaceutical industry or related field
- Experience is a plus
- Ability to work with peers and business contacts in order to communicate basic concepts.
- Ability to read and interpret general documents.
- Ability to write routine reports and general business correspondence.
- Fluent Dutch and English, basic French prefered
- Good planning and organizational skills
- Sense of responsibility and accuracy
- Sense of duty
- Be able to work autonomously
Our client offers competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.