We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia, covering services such as Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. PrimeVigilance provides first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming a global leader in the field. We cover all therapy areas, including medical devices. We invest in our staff through excellent training and development opportunities. We value employee experience, well-being, and mental health, recognizing that a healthy work-life balance is crucial for satisfaction and high-quality client service. Join us on this exciting journey to make a positive impact on patients' lives. Job Description We are seeking a highly skilled and experienced Senior PV Auditor to join our team in the EU. As a key member of our Pharmacovigilance Quality Assurance department, you will ensure compliance with global pharmacovigilance regulations and uphold the highest drug safety standards. Plan, conduct, and lead complex pharmacovigilance audits of internal processes, systems, and external partners. Conduct contracted audits and QA consultancies requested by clients, including PV systems of clients or their affiliates/partners. Develop and implement risk-based audit strategies and annual audit plans. Analyze audit findings, identify trends, and recommend 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 authorities. Contribute to PV quality management systems development and maintenance. Manage multiple audit projects simultaneously, ensuring timely, high-quality deliverables. Qualifications Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's preferred. Extensive experience in pharmacovigilance auditing, including US audits. Deep knowledge of global PV regulations, including EMA and FDA requirements. Strong understanding of GVP and quality management systems. Proven experience in conducting internal and external pharmaceutical audits. Excellent risk assessment, data analysis, and interpretation skills. Superior report writing and presentation abilities. Strong project management skills. Proficiency with 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 in fast-paced environments. Willingness to travel up to 25% for on-site audits. Additional Information Why PrimeVigilance We prioritize diversity, equity, and inclusion by fostering an equal opportunities workplace and a human-centric environment where individuals of all backgrounds can contribute and grow. We believe in a human-first approach, as our people are our greatest strength, driving our success in improving lives. We offer: Internal training and career development opportunities. A focus on personal and professional growth. A friendly, supportive work environment. Opportunities to collaborate with colleagues worldwide, with English as the company language. Our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging—guide our operations. If these resonate with you, PrimeVigilance could be a great place to join! We look forward to receiving your application. J-18808-Ljbffr