Senior Pv Auditor

Prime Vigilance Ltd; Madrid; Presencial; EUR 45.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is on the lookout for a Senior PV Auditor to join their dynamic team in Spain. This role is pivotal in ensuring compliance with global pharmacovigilance regulations and maintaining the highest standards of drug safety practices. You will lead audits, develop risk-based strategies, and mentor junior auditors while contributing to the quality management systems. The company prides itself on a supportive work environment and offers excellent training and development opportunities, making it a perfect place for professionals eager to make a positive impact on patients' lives.

Servicios

Training and career development opportunities

Emphasis on personal and professional growth

Supportive working environment

Opportunity to work with colleagues worldwide

Formación

• Extensive experience in pharmacovigilance auditing, including US auditing.
• In-depth knowledge of global pharmacovigilance regulations and guidelines.

Responsabilidades

• Lead complex pharmacovigilance audits of internal processes and external partners.
• Write comprehensive audit reports and present findings to senior management.

Conocimientos

Pharmacovigilance Auditing

Risk Assessment

Data Analysis

Project Management

Communication Skills

Educación

Bachelor's degree in Pharmacy or Life Sciences

Master's degree

Herramientas

PV Databases

Auditing Tools

Descripción del empleo

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 in 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 by providing 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 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 backgrounds can contribute and grow.

We believe in a human-first approach, as our people are our greatest strength, leading to our success in improving patients' lives.

We offer :

• Training and career development opportunities.
• Emphasis on personal and professional growth.
• Supportive working environment.
• Opportunity to work with colleagues worldwide, with English as the company language.

Our core values :

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging

We look forward to receiving your application.

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