On behalf of our client, we are currently recruiting for an EU QPPV. This is for a company based in Dublin but the role is predominantly remote. The role is part-time position of approx 20 hours per week.
Acting as the EU Qualified Person for Pharmacovigilance that will undertake the following through contract service provider, supported by service level agreement in the areas of:
Act as a single contact point for the Health Authorities (Has) on a 24-hour basis and responding to HAs queries.
Maintain an overview of the safety profiles and any emerging safety concerns for medical products
Maintain a pharmacovigilance system (GPV) in accordance with EU and international legislation to handle Adverse Event Reports (AER’s) and periodic Safety Update Reports (PSUR’s) with overall responsibility for the processing and reporting of safety information to Regulatory Authorities, Licensees, and Distributors.
Document and process all safety data, adverse events, and special situation report(s)ensuring that safety reports are processed and reported according to ICH/EU guidelines, regulatory requirements, and company SOPs or procedures.
Design and implement procedures to ensure the smooth and successful running of the Pharmacovigilance system.
Review safety data.
Ensure the necessary quality, including the correctness and completeness of pharmacovigilance data submitted to the Health Authority
Assist external company medical doctor/physician in review and follow-up of safety information.
Lifecycle maintenance of PV documents such as PBRER’s, PSUR’s, DSUR'S, PSMF, PMP updates, and Annual Safety Reports, and have sufficient authority over the content of risk management plans.
Oversee and maintain Safety Data Exchange Agreements (SDEAs) with a small number of partners and distributors.
Provide training on processing and reporting of safety procedures to other employees as needed.
Perform safety-related training for company staff.
Prepare PV monthly report and organise the PV meetings as per agreed timelines.
Manage 1 direct report
For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
#LI-LD1