Senior PV Auditor

TN Spain; Madrid; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player in pharmacovigilance is seeking a Senior PV Auditor to ensure compliance with global regulations and uphold drug safety standards. In this pivotal role, you'll lead audits, analyze findings, and mentor junior auditors, all while contributing to the development of quality management systems. Join a company that values diversity and employee well-being, offering a supportive work environment and opportunities for professional growth. If you're passionate about making a difference in the pharmaceutical industry, this role is perfect for you.

Servicios

Internal training opportunities

Career development

Supportive work environment

Global collaboration opportunities

Formación

• Extensive experience in pharmacovigilance auditing, including US audits.
• Deep knowledge of global PV regulations, EMA, and FDA requirements.

Responsabilidades

• Plan and conduct complex pharmacovigilance audits of internal processes.
• Analyze audit findings and recommend process improvements.

Conocimientos

Pharmacovigilance Auditing

Risk Assessment

Data Analysis

Project Management

Report Writing

Communication Skills

Educación

Bachelor's degree in Pharmacy

Master's degree in Life Sciences

Herramientas

PV Databases

Auditing Tools

Descripción del empleo

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Company Description and Introduction

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We have achieved consistent global organic growth, with staff across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

PrimeVigilance supports pharmaceutical and biotechnology partners of all sizes, maintaining long-term 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, valuing employee well-being and mental health, recognizing that a healthy work-life balance fosters high-quality client service.

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 ensure compliance with global pharmacovigilance regulations and uphold the highest standards of drug safety practices.

1. Plan, conduct, and lead complex pharmacovigilance audits of internal processes, systems, and external partners.
2. Plan, conduct, and lead contracted audits and QA consultancies requested by clients, including PV systems of clients or their affiliates/partners.
3. Develop and implement risk-based audit strategies and annual audit plans.
4. Analyze audit findings, identify trends, and recommend process improvements.
5. Write comprehensive audit reports and present findings to senior management.
6. Collaborate with cross-functional teams to ensure timely closure of audit observations.
7. Stay current with evolving global pharmacovigilance regulations and industry best practices.
8. Provide guidance and mentorship to junior auditors and team members.
9. Participate in regulatory inspections and support responses to authorities.
10. Contribute to PV quality management systems development and maintenance.
11. Manage multiple audit projects, ensuring timely and high-quality deliverables.

Qualifications and Skills

• 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, EMA, and FDA requirements.
• Strong understanding of GVP and quality management systems.
• Proven experience 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.
• Attention to detail, analytical thinking, and excellent communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel up to 25% for on-site audits.

Why Join PrimeVigilance?

We prioritize diversity, equity, and inclusion, fostering a human-centric environment where all cultural backgrounds, genders, and ages can contribute and grow. Our success depends on working together with a human-first approach because our people are our greatest strength.

We offer:

• Internal training and career development opportunities.
• 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, and Collaborative Partnerships—guide our operations. If these resonate with you, PrimeVigilance could be the right company for you!

We look forward to your application.