Pharmacovigilance Quality Assurance Manager
CK QLS are recruiting for a Pharmacovigilance Quality Assurance Manager to join our client who are a mid sized pharmaceutical company, based just out side Basel, this is a 12 month contract role.
The Role:
The Pharmacovigilance Quality Assurance Manager is a strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations. He/She independently leads and manages the planning, conduct and reporting of PV compliance audit programs and ensures a standardized approach is implemented and maintained across all affiliate sites for PV and the related Quality System.
You Will:
1. Act as a primary contact with internal stakeholders (affiliate, corporate functions), establishing and maintaining effective relationships, driving collaboration and providing expert-level PV knowledge and guidance on complex topics and issues.
2. Act as local PV QA Manager appointed to affiliate sites and ensure implementation of a standardized PV system, consistent with HQ procedures. Support Idorsia affiliate sites as applicable in the establishment, implementation and management of their local PV system.
3. Maintain, improve and assure execution of a risk-based, global PV QA audit program covering internal and external audits to verify adherence to the PV system, as defined in FDA and EMA Regulations.
4. Perform PV QA audits of vendors across affiliate sites as applicable and of affiliates and maintain oversight of QA consultants appointed to perform PV audits on behalf of the company.
5. Ensure audit results are formally and consistently tracked, recorded, reported, trended.
6. Responsible for escalation of significant PV compliance issues to senior management.
7. Provide in a timely manner the necessary QA output to the EU QPPV (and national ASMs, if applicable) to establish and maintain the PSMF Quality section and audit related PSMF annexes.
8. Ensure inspection readiness of vendors conducting PV activities through metric review, vendor audit findings, CAPA generation and review, and training.
9. Ensure procedures for archiving of records at affiliate sites are in line with Idorsia policies.
10. Review the suitability of procedures for CAPA and deviation management, root cause analysis and perform QA effectiveness checks at HQ and at affiliate sites.
11. Ensure appropriate and timely management of non-conformances related to relevant GxP: deviations, change controls, internal and external CAPAs, Quality Events.
Candidate's Requirements:
Strong background in Pharmacovigilance/Drug Safety and holds a master’s degree in a relevant scientific discipline (Pharmacy or other scientific or health related fields), additional knowledge in Quality Assurance/Compliance and Auditing
12. Expert knowledge of international Pharmacovigilance regulations (primarily, EU, US, Health Canada regulations & ICH guidelines) of medicinal products for human use.
13. In-depth knowledge of pharmaceutical industry practices.
14. Experienced in the training of employees on GVP requirements and pharmaceutical industry practices.
15. At least 10 years of QA/industry/health authority experience, including theconduct of PV audits (e.g. at corporate HQ / affiliates; distributors; biopharmaceutical partners).
16. Prior experience in the coordination of Pharmacovigilance inspections performed by Competent Regulatory Authorities, e.g. FDA, EMA, MHRA, ANSM, BfArM, Health Canada, Swissmedic.
17. Languages: fluent in English - knowledge of German and French would be advantageous.
18. Experience in GDP, warehousing and distribution of commercial products and commercial affiliate QA aspects to also act as Affiliate QA Manager/Supply Chain QA manager is an advantage.
19. Proficient in the use of Microsoft Office applications.