Quality Assurance Officer

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.

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

**Job Description**:
The Quality Assurance Officer will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality teams to ensure audits are delivered in line with PrimeVigilance and procedures and global regulations.

The Quality Assurance Officer will perform all activities described, including but not limited to:
**Audit Support**:

- Supports PrimeVigilance functional teams during the pre-audit, audit, and post-audit stages for audits by clients or by PrimeVigilance internal QA function.
- Hosts onsite and remote audits.
- Provides support for regulatory inspections of clients.
- Assists in scheduling client requests for audits/inspection support.
- Coordinates responses to client audit questionnaires

**Administrative support**
- Supports Quality in the tracking of audit status and deliverables.

**Metrics and Key Performance Indicators**
- Supports Quality in the compilation and reporting of metrics and KPIs.
- Collects and collates data from systems and sources.
- Authors reports and summaries

**CAPA Support Activities**
- Supports Quality in the tracking of Deviations and CAPAs.
- Facilitates CAPA response and resolution.
- Inputs data into the global audit CAPA tracker.

**Other Supportive Responsibilities**:

- Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGs
- Supports the PrimeVigilance Senior Leadership team as needed.
- Supports other Quality activities as needed.

**Qualifications**:

- University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master's degree in a scientific discipline, or equivalent advanced degree with experience.
- Demonstrated Pharmacovigilance experience is essential.
- Prior experience in a Quality and/or Compliance role is highly desirable.
- Prior experience in Medical Information, Medical Devices or IT is desirable but not required.
- Experience of using a safety database (e.g., ARISg, ARGUS) desirable but not required.
- Experience of using an electronic Quality Management System desirable but not required.
- Fluent in English
- MS Office 365, particularly good skills in Excel and Word.

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