Job Description 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 More senior colleague may perform tasks assigned as per SOP to more junior position Supporting ICSR SMEs and contributing as one of ICSR SMEs · Supporting ICSR Operational Leads, as applicable · 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 Qualifications Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance Strong previous experience of PV in ideally a CRO environment 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) 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.