Senior PV Auditor

PrimeVigilance; Frankfurt; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior PV Auditor to join their dynamic team. This role is pivotal in ensuring compliance with global pharmacovigilance regulations and maintaining the highest standards of drug safety practices. You will lead complex audits, develop risk-based strategies, and mentor junior auditors while collaborating with cross-functional teams. The company fosters a diverse and inclusive environment, prioritizing personal and professional growth. If you are passionate about making a difference in drug safety and thrive in a supportive atmosphere, this opportunity is perfect for you.

Leistungen

Training and career development opportunities

Strong emphasis on personal and professional growth

Friendly, supportive working environment

Opportunity to work with global colleagues

Qualifikationen

• Extensive experience in pharmacovigilance auditing, including US auditing.
• Strong understanding of Good Pharmacovigilance Practices (GVP).

Aufgaben

• Conduct and lead complex pharmacovigilance audits and QA consultancies.
• Write comprehensive audit reports and present findings to management.

Kenntnisse

Pharmacovigilance Auditing

Risk Assessment

Data Analysis

Report Writing

Project Management

Communication Skills

Ausbildung

Bachelor's degree in Pharmacy or Life Sciences

Master's degree in related field

Tools

PV Databases

Auditing Tools

Jobbeschreibung

We are seeking a highly skilled and experienced Senior PV Auditor to join our team in Guildford, United Kingdom. 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.

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 our clients, including the client's PV system or their affiliates/partners.
3. Develop and implement risk-based audit strategies and annual audit plans.
4. Analyze audit findings, identify trends, and provide recommendations for 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 regulatory authorities.
10. Contribute to the development and maintenance of PV quality management systems.
11. Manage multiple audit projects simultaneously, ensuring timely completion and high-quality deliverables.

Qualifications

1. Bachelor's degree in Pharmacy, Life Sciences, or related field; Master's degree preferred.
2. Extensive experience in pharmacovigilance auditing, including demonstrated experience with US auditing.
3. In-depth knowledge of global pharmacovigilance regulations and guidelines, including EMA and FDA requirements.
4. Strong understanding of Good Pharmacovigilance Practices (GVP) and quality management systems.
5. Proven experience in conducting internal and external audits in the pharmaceutical industry.
6. Excellent risk assessment and management skills.
7. Advanced data analysis and interpretation abilities.
8. Superior report writing and presentation skills.
9. Strong project management capabilities.
10. Proficiency in relevant PV databases and auditing tools.
11. Relevant PV certifications (e.g., RAPS, DIA) are highly desirable.
12. Exceptional attention to detail and analytical thinking.
13. Excellent communication and interpersonal skills.
14. Ability to work independently and as part of a team in a fast-paced environment.
15. 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 in 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.