We are PrimeVigilance (part of Ergomed PLC), 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. 

The Director, PV Operations and Alliance Optimization through oversight of the corporate pharmacovigilance (PV) operations ensures that the outsourced pharmacovigilance activities are conducted in compliance with applicable legislation, by-laws, regional and local guidelines, agreements, company policies and standards globally, whilst ensuring the highest quality of work.

The Director, PV Operations and Alliance Optimization, will act as the champion of strategic partnership to align PV objectives and priorities, leveraging industry best practice, technology and global footprint of PV vendor(s) to enable integration of cross-functional operations and ensure global consistency and regulatory compliance across the entire client portfolio.

• Translate the global corporate strategic objectives articulated by the Chief Medical Officer into pharmacovigilance (PV) action plans and disseminate them to the designated PV vendor to enable efficient management and integration of inter- and intra-operations
• Manage or supervise outsourced PV operations to ensure adherence to established key quality and compliance metrics and compliance with good pharmacovigilance practice (GVP), regulatory requirements, quality standards and business needs
• Facilitate safety compliance across the entire Vaxxinity portfolio via effective oversight and implementation of measures or solutions provided by vendor(s) which may affect other departments and external groups/vendors deliverables (partners, vendors, CROs etc.)
• Manage Vaxxinity’s PV partnership interface and communication for large programs or standalone projects. Represent corporate Lifecycle Safety (clinical and post-marketing) on projects/programs; serve as primary point of contact within Lifecycle Safety for all internal stakeholders (including Clinical Operations, Regulatory Affairs, Legal, Medical Affairs and Business Partners); liaise between internal/external customers and Lifecycle Safety Operational teams
• Act autonomously as the Safety Subject Matter Expert (SSME) or coordinate external SSMEs
• Act as a single point of contact for Governance, Executives and Integrated Partner(s) in construction of proposed solution. Attend Joint Operating Committee Meetings and / or Governance meetings to assess portfolio level quality and compliance metrics, to provide other portfolio level updates, and to partner/align with PV outsourcing vendors
• Assess PV inspection readiness programs; actively contribute during audits and inspections for assigned project(s)/program(s) in alliance with the PV outsourcing vendor to facilitate the compilation of corrective action plans
• Lead or contribute during internal or Vaxxinity-PV vendor escalation meetings to ensure quick response to any quality concerns or PV vendor escalations, ensuring appropriate representatives from external stakeholders and operational management are involved as appropriate
• Manage finances for assigned projects/programs. Update financial systems, revenue recognition, invoicing, project budget review, project financial analysis, etc.
• In collaboration with the assigned outsourcing vendor develop specialized expertise across the realm of pharmacovigilance and apply and cascade knowledge to internal stakeholders as appropriate
• Perform other duties as assigned
• Management of outsourced PV operations to ensure adherence to established key quality and compliance metrics
• Represents PV on project teams, other departments, and committees as needed.

• University degree in healthcare related field
• 8-10 years of applicable experience, out of which at least 5 years direct experience in global pharmacovigilance activities.
• 3-5+ years of experience in management of divers, global teams
• Thorough knowledge and experience in all aspects of global pharmacovigilance systems and processes
• Inspection and audit experience
• Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to optimize the management of the PV activities
• Operational expertise with ARGUS preferred
• Excellent oral and written communication skills
• Strong interpersonal and leadership skills and demonstrated ability to manage, motivate and influence work behaviours of individuals who are not direct reports, like vendors

English – fluent (spoken, written)

Advanced digital literacy (MS Office)

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.