Pharmacovigilance Auditor

Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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 becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.

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.

**Job Description**:
**Principal Responsibilities**

Conduct audits initiated by PrimeVigilance, according to the agreed Audit Plan including effective management of pre-audit and post-audit activities.
- Audits of PrimeVigilance’s Partners and Vendors/Service Providers.
- Internal Audits of Projects and Processes.
- Audits of Third Parties on behalf of Clients.

Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines.

**Principal Functions and Responsibilities may include the following**:
Audit - internal
- Effective management of pre-audit activities: Communication with Auditee, preparation of Quality Plan, Audit Plan, Audit Checklist, etc. in agreed formats and timelines.
- Conduct audits initiated by PrimeVigilance in line with agreed Audit Plan and Quality Plan.
- Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines.
- Plan, create and maintain Corrective and Preventative Action Plans if needed, on an assigned audit basis.
- Act as Lead Auditor on an assigned audit basis: Manage Audit Team in the performance of audits, ensuring that audits comply with applicable PrimeVigilance and/or client procedures and local and global regulatory requirements as well as contractual agreements.

Audit as a service
- Conduct Audits of Third Parties on behalf of Clients in line with agreed Audit plan and Client´s specification.
- Writes/reviews all Third-Party audit reports before distribution to client.

CAPA
- Reviews and approves all final CAPA plans where needed from internal audits and client audits within timelines mandated by PrimeVigilance and/or client procedures.

Other Supportive Responsibilities
- Participate in workshops or trainings organized by PrimeVigilance and create/develop and present training to PrimeVigilance staff on applicable regulatory requirements.

**Qualifications**:
B.Sc. in a scientific, preferably healthcare-related, field.

A minimum of 4 years pharmaceutical and/or biotech pharmacovigilance experience, with a understanding of GVP-related Quality Management and Assurance, and 2 years GxP auditing experience in an Audit Lead role.

GxP Knowledge: In-depth knowledge of the applicable GxP regulations e.g., EU and FDA regulations particularly EU GVP.

Analytical written and oral communication skills.

Able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines.

Ability to think strategically and to work collaboratively using risk-based, proactive approaches to problem solving.

Strong team player

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
- Collaborative Partnerships