PV Associate

Job description

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 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 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 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 Requirements: Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance 0-1 year of experience in pharmacovigilance, desirable but not required Organization skills, including attention to detail and multitasking Management skills, including time and issue management English - advanced (spoken, written) Advanced literacy (MS Office) 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 We look forward to welcoming your application.