Main Purpose of role:
This role is responsible for managing and supervising activities related to the detection, assessment, understanding and prevention of adverse events and reactions or any other drug safety-related issues on behalf of the Arriello or Clients which subcontract Arriello for EU QPPV office.
- Have sufficient authority over the pharmacovigilance system in order to promote, maintain and improve compliance. Develop and maintain the Pharmacovigilance System Master Files (PSMFs) ensuring that the PSMFs are accurate and up-to-date reflections of the pharmacovigilance system.
- Act as a responsible person and administrator for EudraVigilance for Arriello and clients which subcontract pharmacovigilance to Arriello
- Establish and maintain the system, which ensures that all safety information reported to Arriello/Client on investigational, authorised and marketed medicinal products is collected, evaluated and collated and accessible at least at one point within the EEA.
- Have awareness of risk minimisation measures (RMMs) and when applicable provide a medical input (through your own knowledge and consults the medically trained designee when applicable) into them.
- Provide medical input (through your own knowledge and consults the medically trained designee when applicable) into Risk Management Plans (RMP) and have authority over content of the RMP. Act as final signatory for RMPs for products under scope.
- Provide medical input (through your own knowledge and consults the medically trained designee when applicable) Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR) have authority over content of the PSUR/DSUR. Act as final signatory for PSURs/DSURs for products under scope.
- Review and approve of protocols of Post Authorisation Safety Studies (PASS) conducted in the EU or pursuant to a RMP agreed to in the EU
- Act as a single point of PV contact for competent authorities in Member States and the Agency on a 24-hour basis and as contact point for PV inspections
- Ensure that procedures are in place to assure the required reports are sent to competent authorities of the Member States and the European Medicines Agency (EMA) as well as other Health Authorities (as applicable) within regulatory timelines and relevant monitoring mechanisms are in place. The required reports include:
- Individual Case Safety Reports (ICSR)
- Periodic Safety Update Reports (PSUR)
- Development Safety Update Report (DSUR)
- Ensure that any request from the competent authorities for the provision of additional information necessary for the evaluation of the risks and benefits of a medicinal product is answered fully and promptly, including the provision of information regarding the volume of sales or prescriptions for the medicinal product concerned.
- Provide the competent authorities, with any other information that may be relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on PASS.
- Ensure that all products in scope are continuously evaluated. The EU QPPV is actively involved in safety issue management.
- Ensure the continuing evaluation of the benefit/risk analyses of all products in scope. Ensure that signal detection and trending mechanisms are in place. Ensure that when a safety signal or alert is identified all appropriate actions are initiated in accordance with the relevant procedures.
- Integrate the PV processes into an appropriate Quality Management System (of Arriello and Client), i.e. adequate Quality system documents, training, compliance measurements and system audits.
- Provide input into contractual arrangements – SDEAs with business partners, project specific agreements with service providers and PV service agreements between Arriello and Client
- If the conditions for an Emerging Safety Issue are fulfilled, ensure that the EMA and Health Authorities in relevant countries are contacted immediately ensuring prompt evaluation, including potential recall situations.
- Carry out your accountabilities in close cooperation with the Deputy EU QPPV and Quality Manager of Arriello.
- Ensure that the conduct of PV and submissions of all PV-related documents is in accordance with legal requirements and Good Pharmacovigilance Practice, EU pharmacovigilance Regulations, Directives and applicable regulations and guidance.
- Maintain up-to-date knowledge of PV regulations.
- Ensure back-up procedures are appropriately maintained and tested including PV business Continuity, Disaster Recovery and Deputy EU QPPV
- Have following responsibilities in connection to the Local Person for Pharmacovigilance (LPPV):
- Maintain an oversight of project specification documents in place
- Be responsible for approval of the vendors contracted/subcontracted for the role of LPPV by cooperating with the Vendor Manager and Head of Local PV Unit
- Oversee the LPPV training and compliance with the LPPV tasks and responsibilities
- Initiates reconciliation reports with the LPPVs according to the agreement
- Assists Quality Manager with audits of the vendors if required
- Lead by example to ensure effective and cooperative cross-functional teamwork
- Serve as a functional expert, which includes but is not limited to knowledge of the services required, local laws and regulations
- Ensure that all processes and all business partners are in compliance with company and regulatory requirements
You should have:
- At least Bachelor degree in Pharmacy or Life Science
- Significant pharmacovigilance experience across EU
- Experience of working with external partners
- Relevant EU and/or other markets pharmacovigilance training
- Interesting role in an international environment (full-time)
- 25 days holiday
- Multisport card, refreshments at the workplace
- Performance bonuses
- Meal vouchers
- Flexible working hours
Please note that only English CV will be accepted and only selected candidates shall be contacted for further process.
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