(Junior) Pharmacovigilance & Materiovigilance Officer
+32 494 04 21 32
Description de l'emploi
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