PV Associate - English & Dutch

Job Description

• Assures and exerts activities leading to effective cooperation with clients in the area of ICSR Management
• Contributes to achieving company’s goals and objectives
• Works under supervision of more experienced colleague
• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
• Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, Prime Vigilance procedures and in accordance with client specific requirements and timelines
• Performing ICSR follow up
• SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
• Reconciliation (clinical, partners)
• Product Quality Complaint handling and interaction with Quality Assurance
• Medical Information interaction
• Database Outputs and Reports (including data for monthly reporting to clients)

We expect:

• Interested in pursuing a career in pharmacovigilance
• Fluency in English & Dutch
• Good IT skills (MS Office)
• People who are excited to learn and contribute to patient safety
• Excellent organization skills with attention to detail
• Excellent interpersonal and communication skills

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 Prime Vigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.