Offer summary

Qualifications:

Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's degree preferred., Extensive experience in pharmacovigilance auditing, including US auditing., In-depth knowledge of global pharmacovigilance regulations and guidelines, including EMA and FDA requirements., Strong project management capabilities and excellent communication skills..

Key responsibilities:

Plan, conduct, and lead complex pharmacovigilance audits of internal processes and external partners.

Develop and implement risk-based audit strategies and annual audit plans.

Write comprehensive audit reports and present findings to senior management.

Collaborate with cross-functional teams to ensure timely closure of audit observations.

Job description

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.

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 our clients, including the client's PV system or their affiliates/ partners
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
Manage multiple audit projects simultaneously, ensuring timely completion and high-quality deliverables

QUALIFICATIONS

Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's degree preferred
Extensive experience in pharmacovigilance auditing, including demonstrated experience with US auditing,
In-depth knowledge of global pharmacovigilance regulations and guidelines, including EMA and FDA requirements
Strong understanding of Good Pharmacovigilance Practices (GVP) and quality management systems
Proven experience in conducting internal and external 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
Relevant PV certifications (e.g., RAPS, DIA) are highly desirable
Exceptional attention to detail and analytical thinking
Excellent communication and interpersonal skills
Ability to work independently and as part of a team in a fast-paced environment
Willingness to travel as required for on-site audits (up to 25% of the time), if needed

Required profile