Global Quality, Clinical Trials & Safety is responsible for auditing all processes related to clinical research and pharmacovigilance activities, to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator sites, internal systems and external vendor audits. GQ CT&S is also responsible for the management of regulatory agency inspections and for providing advice on regulatory requirements.
The candidate will be responsible for:
• Performing Pharmacovigilance audits, including audits of critical processes, affiliates, service providers/vendors and licensing partners to assess regulatory compliance, through:
- Applying audit principles, procedures, and methods to prioritize and focus on matters of significance;
- Collecting information through effective interviewing, listening, observing and reviewing documents, records and data;
- Evaluating independently and critically the quality management system and operations, balancing weaknesses against requirements and expectations;
- Confirming the sufficiency and appropriateness of audit evidence to support audit findings and conclusions;
- Assessing those factors that may affect the reliability of the audit findings and conclusions;
- Performing and documenting analyses of audit findings where indicated:
- Preparing clearly-written, concise, accurate and evidence-based audit report;
- Maintaining the audit management database;
- Reviewing and assessing corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence.
• Participating in the preparation, hosting and follow-up of regulatory authority inspections related to clinical safety and pharmacovigilance activities at central sites, affiliates and partners/vendors;
• Participating in due diligence activities and qualification audits of potential new vendors/partners;
• Maintaining an in-depth knowledge of Clinical Safety and PV system regulations as they apply throughout a product’s life-cycle;
• Providing advice and counsel concerning GVP regulatory requirements;
• Mentoring of new GQ-CT&S staff, as required.