Medical Reviewer I

Company DescriptionWe are PrimeVigilance part of Ergomed PLC 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 For 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 issues To review and provide input in Periodic Safety Update Reports Development Safety Update Reports literature screening search strategy To review articles to determine if they contain ICSRs SAEs related to the relevant Medicinal Product or other safety related findings To cooperate in the preparation of and provide input in Risk Management Plans Supporting the preparation of responses to regulatory authority requests Signalling Reviewing line listings Participating 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 minimisation Evaluating and categorizing possible signals and proposing a course of action Supporting preparation and review of benefit-risk reports Qualifications The PV Physician should be medically qualified as a physician Previous experience in pharmacovigilance Ability to review different aggregate report types including PBRERs and DSURs Expertise in signal detection activities is essential Excellent interpersonal skills Ability to plan organise prioritise and execute multiple tasks Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork Communication skills Presentation skills English - 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 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 Come and join us in this exciting journey to make a positive impact in patients lives We look forward to welcoming your application