On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Pharmacovigilance Coordinator.
The Pharmacovigilance Coordinator is responsible for supporting the PV department in relation to document management and incoming safety data. The PV Coordinator is a member of the Case processing team ensuring the accurate distribution and co-ordination of case safety reports. The CWM team works together to collect and collate all reports of suspected adverse reactions associated with medicinal products for human use originating from unsolicited or solicited sources.
Responsibilities: Pharmacovigilance Support
Distribution and co-ordination of inbound PV data (mainly case safety reports) Daily screening of data base modules and PV inboxes, receipt, tracking and archivin Updating the PV database to record ICSR reporting dates to Regulatory Authorities Assisting with team training preparation and organization Maintenance of PV tracking systems Co-ordination of PV projects and pursuits All other ad hoc PV activity duties as required by the business needs Collection and arrangement of data relating to Quality & Compliance Aiding with administrative tasks relating to the Pharmacovigilance activities Supporting the PV department in relation to document management Providing assistance for PV activities such as reconciliation and liaising with affiliates as required Maintain awareness of company products in order to assess incoming information for any safety related information Adhere to agreed Key Performance Indicators (KPIs).
2 years plus in an executive secretarial/Administration/Project environment preferably in the medical or pharmaceutical industry Advanced computer experience (Application Software Packages, Data Capturing, MS Office (all programs) Working in a busy office environment Report writing, Information gathering and monitoring General Pharmacovigilance knowledge an advantage Ability to prioritise, plan and organise work with an appropriate sense of urgency based on regulatory requirements and business needs Detail oriented, ability to multi-task and work with a high degree of accurac Highly organized with excellent Time Management Maintain rigorous adherence to written procedures (SOPs) Ensure Good Documentation Practices (GDP)
For more information and to apply for this role please call Linda on 1 or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1