We are seeking a highly skilled and experienced Senior PV Auditor to join our team in Spain.
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.
Responsibilities
* 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
We look forward to welcoming your application.
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