This global speciality pharmaceutical organisation are seeking an experienced PV Quality Management and Compliance Manager to join the PV team based at their offices in Citywest, Dublin. This role reports to the Head of Pharmacovigilance who is also based in Dublin.
Duties and responsibilities of the PV Quality Management and Compliance Manager will include but are not limited to:
- Ensure the company's PV responsibilities regarding marketed products in EU and globally are fully met with regards to the pharmacovigilance quality management system.
- Ensure appropriate Quality Management Systems are utilized both internally and externally (in the case of affiliates), in compliance with group policies and procedures and national/EU legislation and guidelines.
- Provide PV support for all audits including external audits for Logistics Service Providers, Distribution Centres and non-PV Vendors which would involving participation in audits, review of audit report and auditing findings and review and approval of any CAPAs identified.
- Inspection support, vendor management, change and CAPA management and regulatory intelligence activities.
- Support safety data reporting processes and procedures (working with appropriate and relevant divisional management) are compliant with national legislation.
- Compile monthly and annual compliance reports. Ensure all non-compliances are investigated and deviations raised where necessary, identifying root causes and ensuring the relevant PV personnel implement adequate and timeous corrective and preventative action (CAPA).
- Implement, maintain and comply with local PV QMS documents in accordance with Group Guidelines, Policies and Procedures, IMB guidance, EU legislation and guidelines.
- To keep colleagues and Group informed of any information (including updates to EU legislation) which may be relevant to their ability to complete their duties effectively.
To be considered for this position you will have skills and experience in the following:
- BSc and 3+ years within PV or similar areas across Pharma / CRO / Biotech / Consultancy including exposure to inspections.
- 3+ years in Quality Management Systems and Pharmacovigilance within the pharmaceutical industry.
- Experience in conducting Pharmacovigilance audits (Qualification as an auditor preferred).
- Several years of PV/clinical/industry/Regulatory Authority or otherwise relevant experience.
- Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Medical Governance, Clinical Development, Regulatory Affairs and Pharmacovigilance
- Projects (advantage).
- Excellent oral and written English communication.
- Change Management.
- Preparing and organizing for audits.
- Contracts (Safety Data Exchange Agreements, MAH Agreements).
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.