PV Associate - English & Dutch

PrimeVigilance; Guildford; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global pharmacovigilance company in the UK is seeking a candidate to manage ICSR activities, ensuring compliance with regulations and supporting client projects. The role emphasizes language skills in English and Dutch, alongside excellent organizational and communication abilities. Opportunities for development in a diverse, inclusive working environment are provided. This position aims to enhance patient safety and improve lives globally.

Benefits

Training and career development opportunities

Friendly, supportive working environment

Qualifications

• Interest in pursuing a career in pharmacovigilance.
• Excited to learn and contribute to patient safety.

Responsibilities

• Assure effective cooperation with clients in ICSR Management.
• Process Individual Case Safety Reports (ICSRs) in compliance with regulations.
• Perform ICSR follow-up and SAE/SUSAR Management.

Skills

Fluency in English & Dutch

Good IT skills (MS Office)

Excellent organization skills with attention to detail

Excellent interpersonal and communication skills

Job description

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, PrimeVigilance 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)

Qualifications

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

Additional Information

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.