Senior PV Associate

Company Description

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. 

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. 

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them. Senior PV Associates are expected to reach and maintain a high level of performance within 5 months of being assigned to an ICSR team, following onboarding completion. 

Responsibilities include:

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. 

• Reconciliation activities for all types of received reports 

• Workflow management activities 

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. 

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them. Senior PV Associates are expected to reach and maintain a high level of performance within 5 months of being assigned to an ICSR team, following onboarding completion. 

Responsibilities include:

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. 

• Reconciliation activities for all types of received reports 

• Workflow management activities 

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. 

Our Offer

• Competitive salary
• Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
• Friendly working environment with several social events per year

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