We are PrimeVigilance (part of Ergomed Group), 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.

· Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR

Management

· Contributes to achieving company´s goals and objectives

· Works independently

Clinical case processing SME

ROLE AND RESPONSIBILITIES

· 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

· Mentoring and training of new and more junior employees within the department

· Support of PV processes related to the ICSR management within PrimeVigilance and also to

clients

· Supporting ICSR SMEs or contributing as one of ICSR SMEs

· More senior colleague may perform tasks assigned as per SOP to more junior position

· Performing activities in the scope of ICSR management unit within agreed extent and timeframe

· Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance

3-4 years of work experience in pharmacovigilance including clincial

· Excellent communication (written and verbal) skills

· Organization skills, including attention to details and multitasking

· Delegation skills

· Planning and time management

· Technical skills

· Team working

English – fluent (spoken, written)

Advanced 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.