Company Description

We are PrimeVigilance (part of Ergomed PLC), 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.  

Job Description

At PrimeVigilance, Senior PV Associates are experienced case processing team members who are expected to manage a variety of case processing services with minimal guidance from senior team members. 

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) 

Personal data protection 

Product Quality Complaint handling and interaction with Quality Assurance 

Medical Information interaction 

MedDRA and WHO coding 

Database Outputs and Reports (including data for monthly reporting to clients) 

Workflow & resource management 

Qualifications

Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing    

ARGUS experience preferred 

Time and issue management, delegation, organization and multitasking skills with good attention to detail   

Strong interpersonal and communication skills   

Advanced English skills, both verbal and written, at least B2   

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.