Pharmacovigilance Quality Assurance Manager, Basel

Vor 2 Tagen

Basel, Schweiz TN Switzerland Vollzeit

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Pharmacovigilance Quality Assurance Manager, BaselClient:

CK Group

Location:

Basel

Job Category:

Other

Job Reference:

99fb348aa715

Job Views:

9

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

Pharmacovigilance Quality Assurance Manager

CK QLS are recruiting for a Pharmacovigilance Quality Assurance Manager to join our client, a mid-sized pharmaceutical company based just outside 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 obligations 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, ensuring 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 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, and 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 the conduct 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.
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