Senior PV Auditor

Experteer Italy; Roma; In loco; EUR 50.000 - 90.000; Tempo pieno

Descrizione del lavoro

Join a forward-thinking pharmacovigilance service provider as a Senior PV Auditor. In this pivotal role, you will lead complex audits, ensuring compliance with global regulations and maintaining high standards of drug safety practices. You will analyze findings, mentor junior auditors, and contribute to the development of quality management systems. This position offers opportunities for professional growth in a supportive environment that values diversity and inclusion. If you're passionate about making a positive impact on patient safety and thrive in a dynamic team, this is the perfect opportunity for you.

Servizi

Training and Career Development

Supportive Environment

Global Work Opportunities

Competenze

• Extensive pharmacovigilance auditing experience, including US audits.
• In-depth knowledge of EMA and FDA regulations.

Mansioni

• Plan and conduct complex pharmacovigilance audits.
• Analyze audit findings and recommend process improvements.
• Collaborate with cross-functional teams for timely audit closure.

Conoscenze

Pharmacovigilance Auditing

Risk Assessment

Data Analysis

Report Writing

Project Management

Communication Skills

Formazione

Bachelor's in Pharmacy

Master's in Life Sciences

Strumenti

PV Databases

Descrizione del lavoro

Company Description
Introduction
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 employee 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 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 for our clients, including their PV systems or 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 the development and maintenance of PV quality management systems.
11. Manage multiple audit projects simultaneously, ensuring timely and high-quality deliverables.

Minimum qualifications include a Bachelor's degree in Pharmacy, Life Sciences, or a related field (Master's preferred), extensive pharmacovigilance auditing experience (including US audits), and in-depth knowledge of EMA and FDA regulations. Strong understanding of GVP and quality management systems, excellent risk assessment, data analysis, report writing, project management skills, and proficiency with PV databases are required. Relevant certifications such as RAPS or DIA are highly desirable. Must have attention to detail, excellent communication skills, and willingness to travel up to 25% for on-site audits.

Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment. Our people are our greatest strength, driving our success in improving lives.

We offer training and career development, a supportive environment, and opportunities to work globally with English as the company language. Our core values include Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships.

We look forward to your application.