PV Quality Management Lead

A global Pharma is looking for an experienced Pharmacovigilance Quality Assurance Lead to support Quality oversight. This is an exciting opportunity in Switzerland to successfully lead a Quality Assurance team.

Job Responsibilities

• Manage the development and implementation of a risk-based global PV Audit program (including audits of Affiliates, Distributors, Contractors, special programs and systems) in support of clinical safety and Pharmacovigilance activities related to Vifor products.
• Set up a robust Pharmacovigilance quality system at Vifor Pharma
• Monitor and assess global safety processes and procedures for consistency and compliance with global laws, regulatory requirements and Vifor policies and procedures.
• Provide guidance and expert advice and act as point of contact in relation to interpretation of PV regulations, quality improvement, process and program initiatives and risk assessment for the Global Drug Safety Department (GDS) and all other stakeholders (Medical Affairs, Regulatory Affairs, Clinical Development, etc.) which are impacted by Good Pharmacovigilance Practices (GPvP).
• Lead the preparation, hosting and follow up of Regulatory Authorities inspections related to Pharmacovigilance activities at Vifor Pharma, including Affiliates.
• Monitor deviations at Global drug safety, escalate as necessary and maintain CAPA oversight for all audits and Inspections.
• Generate and provide metrics, status and trend reports and other information, as required by management

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.

#LI-JG1