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 all covering services within : Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Job Description
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.
* 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.
Additional Information
Why PrimeVigilance
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer :
* Training and career development opportunities internally.
* Strong emphasis on personal and professional growth.
* Friendly, supportive working environment.
* Opportunity to work with colleagues based all over the world, with English as the company language.
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
* Quality
* Integrity & Trust
* Drive & Passion
* Agility & Responsiveness
* Belonging
We look forward to welcoming your application.
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