Medical Reviewer I

PrimeVigilance

  • Comunidad de Madrid
  • Permanente
  • Tiempo completo
  • Hace 13 días
  • Solicite fácilmente
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 (May include but is not limited to the following):To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, listedness/expectedness and company causality, as well as writing of company comment, follow-up questions and analysis of similar events, when required. Including completion of all required supporting documentation such as trackers.To review literature screening search strategyTo review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Productor other safety related findingsReviewing database outputsTo review and provide input in Periodic Safety Update ReportsTo review and provide input in Development Safety Update ReportsParticipating in signal detection activities including meetings and writing signal detection reportsProposing a course of action whenever a possible signal is identifiedFor the Company (This may include but is not limited to):Writing PV ProceduresMentoring less experienced PhysiciansQualifications
  • Medically qualified as a physician with demonstrated experience in Pharmacovigilance
  • Any experience in aggregate reports and signal detection is desirable
  • 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
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 patient’s lives. We look forward to welcoming your application.#LI Remote

PrimeVigilance