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Job type: Permanent

Discipline: Good Pharmacovigilance Practice (GVP)

Location: United Kingdom

A global Pharma is looking for an experience Quality Assurance Manager PV to support Quality oversight.

Job Responsibilities

Manager, PV QA supports all the GVP QA responsibilities as listed below. Different members of the team will have specific focus areas:
Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
Support cross GxP QA activities requiring PV expertise, as requested.
Determine, evaluate, and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions.
Effectively communicate and escalate quality concerns and critical matters to management.
Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.
Develop and maintain processes and tools to support quality audit execution and outcomes.
Support PV / post-marketing surveillance inspection readiness and inspection management activities.
Support Quality oversight activities for PV and PV related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs and audits.
Develop and report PV QA metrics and dashboards to support Quality oversight.

Skills and Requirements

Educated to university degree (preferably life sciences) or equivalent qualification or experience
Experience in the Pharmaceutical industry in a quality or compliance function, GxP auditing, pharmacovigilance, regulatory affairs, and/or clinical research.
Audit skills, and experience of conducting GVP audits is preferred.
Knowledge of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances and ICH.

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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