(Senior) PSMF Officer

We are PrimeVigilance (part of Ergomed Group), 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.

The position is primarily responsible for the creation and maintenance of client Pharmacovigilance System Master Files, in line with global regulations, legislation, PrimeVigilance and Client requirements.

• The position will maintain and manage PSMF for clients,
• Activities will include PSMF:
  • Authoring
  • Revision
  • Quality check review
  • Tracking
• Attend regular PSMF meetings with internal employees and Clients.
• May take responsibility in audits/inspections when scope is applicable to the PSMF department.
• Revision and update of PSMF related quality documents.

• Degree qualification preferred, ideally in life sciences - pharmacy, nursing or other healthcare related qualification.
• Organisational skills, including attention to detail and multi tasking.
• Management skills, including time and issue management.
• Excellent communication skills
• Advanced English (spoken and written)
• Previous experience with Pharmacovigilance is required.
• Previous experience with PSMF creation is required.

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

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.