Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed

Company Description

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. 

Job Description

• Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader and Line Manages ICSR staff
• Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process 
• 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 under supervision of ICSR Operational Lead
• ​​Role and Responsibilities​ 
• Providing support to other activities undertaken by the project team on behalf of the client and the company 
• Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency) 
• Proposes process changes to ICSR Operational Lead 
• Manages ICSR deviations with ICSR Operational Lead support 
• Reviews trackers and timesheet data and ensures accuracy 
• Is involved in ICSR processing and 2nd QC of cases 
• Support other departments, as approved and instructed by ICSR Operational Lead 
• Operates as the assigned team SME 
• 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 

Qualifications

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance 
• Strong previous work experience in pharmacovigilance within which minimum 1 year of work experience in line manager role.  
• Medical Device experience required
• 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) 

Additional Information

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.