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Company DescriptionWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially 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 becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.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.Job DescriptionFor the Client:To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issuesTo review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategyTo review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findingsTo cooperate in the preparation of and provide input in Risk Management PlansSupporting the preparation of responses to regulatory authority requestsSignallingReviewing line listingsParticipating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisationEvaluating and categorizing possible signals and proposing a course of actionSupporting preparation and review of benefit-risk reportsQualificationsThe PV Physician should be medically qualified as a physicianPrevious experience in pharmacovigilanceAbility to review different aggregate report types including PBRERs and DSURsExpertise in signal detection activities is essentialExcellent interpersonal skillsAbility to plan, organise, prioritise and execute multiple tasksAbility to work effectively cross-culturally and cross-functionally and value the importance of teamworkCommunication skills Presentation skillsEnglish – advanced (spoken, written)Japanese – advanced (spoken, written)Advanced literacy (MS Office)Additional InformationWhy PrimeVigilanceWe 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 OfferTraining 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 Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.
