Senior PV Auditor

Prime Vigilance Ltd; Warszawa; On-site; EUR 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Senior PV Auditor to join their dynamic team. In this pivotal role, you will ensure compliance with global pharmacovigilance regulations while leading audits and providing guidance to junior auditors. This position offers the opportunity to work in a supportive environment that values personal and professional growth. With a strong emphasis on employee well-being, you will be part of a team dedicated to making a positive impact in the pharmaceutical field. Join this innovative firm and contribute to improving patient safety worldwide.

Benefits

Training and career development opportunities

Friendly, supportive working environment

Opportunity to work globally

Qualifications

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

Responsibilities

• Lead complex pharmacovigilance audits and develop audit strategies.
• Collaborate with teams to ensure timely closure of audit observations.

Skills

Pharmacovigilance Auditing

Risk Assessment

Data Analysis

Report Writing

Project Management

Communication Skills

Education

Bachelor's degree in Pharmacy

Master's degree in Life Sciences

Tools

PV Databases

Auditing Tools

Job description

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 all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large 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 device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

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.

• 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 deomonstrated experiencewith 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 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 on 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.