We are a leading mid-size pharmacovigilance service provider established in 2008, part of Ergomed Group. We take pride in our global organic growth year after year, with staff based across Europe, North America and Asia covering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
Our company provides first-class support to 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 devices.
We invest in our staff by providing an excellent training and development platform. Employee experience, well-being and mental health are highly valued, and we acknowledge that a healthy work-life balance is critical for employee satisfaction and high-quality client service.
Job Description
Senior PV Auditor
We are seeking a highly skilled and experienced Senior PV Auditor to join our team in Spain.
This role will play a crucial part in ensuring compliance with global pharmacovigilance regulations and maintaining the highest standards of drug safety practices as a key member of our Pharmacovigilance Quality Assurance department.
Key Responsibilities:
* Plan, conduct, and lead complex pharmacovigilance audits of internal processes, systems, and external 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.
Requirements:
* 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.
What 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 BrightVision Capital Partners LLC could be a great company to join
* Quality
* Integrity & Trust
* Drive & Passion
* Agility & Responsiveness
* Belonging