Pharmacovigilance Quality Assurance Manager

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 :

• 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.
• 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.

• 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.
• 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.
• Ensure audit results are formally and consistently tracked, recorded, reported, trended.
• Responsible for escalation of significant PV compliance issues to senior management.
• 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.
• Ensure inspection readiness of vendors conducting PV activities through metric review, vendor audit findings, CAPA generation and review, and training.
• Ensure procedures for archiving of records at affiliate sites are in line with Idorsia policies.
• Review the suitability of procedures for CAPA and deviation management, root cause analysis and perform QA effectiveness checks at HQ and at affiliate sites.
• 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

• Expert knowledge of international Pharmacovigilance regulations (primarily, EU, US, Health Canada regulations & ICH guidelines) of medicinal products for human use.
• In-depth knowledge of pharmaceutical industry practices.
• Experienced in the training of employees on GVP requirements and pharmaceutical industry practices.
• At least 10 years of QA / industry / health authority experience, including theconduct of PV audits (e.g. at corporate HQ / affiliates;

distributors; biopharmaceutical partners).

Prior experience in the coordination of Pharmacovigilance inspections performed by Competent Regulatory Authorities, e.

g. FDA, EMA, MHRA, ANSM, BfArM, Health Canada, Swissmedic.

• Languages : fluent in English - knowledge of German and French would be advantageous.
• 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.
• Proficient in the use of Microsoft Office applications.
Vor 6 Tagen