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 PV Manager leads safety database oversight, ensuring data quality, regulatory compliance, and system optimization. This role supports reporting, validation, training, and cross-functional collaboration while driving continuous improvement and team mentorship.

Role and Responsibilities

• Lead the development and delivery of complex standard and custom reports to meet evolving regulatory requirements and strategic internal needs.
• Oversee database design, set-up, and configuration, ensuring alignment with protocol and product-specific requirements in collaboration with IT, Safety, and Project Management teams.
• Lead validation efforts for computerized PV systems, maintaining compliance with GxP, 21 CFR Part 11, and other regulatory frameworks.
• Strategically manage data migration activities between legacy and modern safety databases, ensuring integrity, traceability, and completeness throughout.
• Develop and deliver advanced training programs on safety database processes, ensuring smooth onboarding and upskilling across regions.
• Act as a Subject Matter Expert (SME) for safety system configurations supporting global pharmacovigilance processes.
• Oversee Cumulative Data Quality Reviews (CDQRs), and drive proactive data integrity initiatives across safety platforms.
• Drive the creation, implementation, and refinement of SOPs, guidelines, and work instructions pertaining to safety database operations.
• Champion continuous improvement initiatives to optimize database performance, user experience, and compliance posture.
• Collaborate with global cross-functional teams (IT, QA, Regulatory, PV Operations, and Commercial) on system enhancements, issue resolution, and client delivery excellence.
• Provide strategic input and support to the Business Development and Commercial teams for proposals, RFPs, and client engagements, representing safety systems capabilities.
• Mentor and coach junior PV team members, building internal capabilities around safety systems and process excellence.
• Represent the PV Systems function in audits and inspections, and ensure readiness of database-related documentation and processes.

• Life Science or Project Management, Business Analysis or IT Development Related Degree 
• Demonstrated knowledge and experience with pharmacovigilance systems in a pharmaceutical company, biotech or CRO (on premise or cloud-based solution)
• Organizational skills, including attention to detail and multitasking
• Management skills, including time and issue management
• Communication skills
• Presentation skills
• Ability to motivate/coach people
• Leadership skills

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  

We look forward to welcoming your application.