Senior Pharmacovigilance Auditor - Remote

Overview

We are seeking a highly skilled and experienced Senior PV Auditor to join our team in Guildford, United Kingdom. As a key member of our Pharmacovigilance Quality Assurance department, you will play a crucial role in ensuring compliance with global pharmacovigilance regulations and maintaining the highest standards of drug safety practices.

In Short

• Plan, conduct, and lead complex pharmacovigilance audits of internal processes, systems, and external partners
• Plan, conduct and lead contracted audits and QA consultancies requested by clients
• Develop and implement risk-based audit strategies and annual audit plans
• Analyse audit findings, identify trends, and provide recommendations for process improvements
• Write comprehensive audit reports and present findings to senior management
• Collaborate with cross-functional teams to ensure timely closure of audit observations
• Stay current with evolving global pharmacovigilance regulations and industry best practices
• Provide guidance and mentorship to junior auditors and team members
• Participate in regulatory inspections and support responses to regulatory authorities
• Contribute to the development and maintenance of PV quality management systems

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's degree preferred
• Extensive experience in pharmacovigilance auditing
• In-depth knowledge of global pharmacovigilance regulations and guidelines
• Strong understanding of Good Pharmacovigilance Practices (GVP)
• Proven experience in conducting audits in the pharmaceutical industry
• Excellent risk assessment and management skills
• Advanced data analysis and interpretation abilities
• Superior report writing and presentation skills
• Strong project management capabilities
• Proficiency in relevant PV databases and auditing tools

Benefits

• Training and career development opportunities
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues globally