ICSR Operational Lead

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.  Resolves assignments from Board, President, SDMD Head and Director of ICSR  Line Manages assigned Team Leads and supports their teams  Ensures effective Line Management in assigned teams (up to 15 direct reports/line manager)  Reviews project resourcing and ensures proactive assignment to avoid/minimize backlogs  Supports Business Development and Proposals with any existing and new opportunities  Supports Team leads with deviation management  Reviews and approves all minor and major CAPAs from the ICSR Management Unit  Supports other departments, as agreed with Director of ICSR  Works independently, with support from Director of ICSR  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 Strong experience in pharmacovigilance Previous Line Management experience   Excellent communication (written and verbal) skills  Excellent organization skills, including attention to details and  multitasking  Excellent management skills, including delegation skills, time and issue management  Technical skills  Team working  English – fluent (spoken, written) 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.