Pharmacovigilance Specialist

hace 3 semanas

Desde casa, México IQVIA A tiempo completo

**Job Overview**Review, assess, and process safety data and information across service lines, received from various sources. Distribute reports/data to both internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members. **This is a trilingual role requiring fluency in English, Spanish, and French.****Main Responsibilities**- Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.- Perform pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AEs) and endpoint information, determining initial/update status of incoming events, database entry, coding AEs and products, writing narratives, and literature-related activities.- Ensure compliance with quality, productivity, and delivery standards per project requirements.- Liaise with different functional team members and healthcare professionals to address project-related issues.- To Prioritize and complete the assigned trainings on time.- Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.- Liaise with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.- May liaise with client in relation to details on day-to-day case processing activities.- To mentor new teams members, if assigned by the Manager.- Perform other duties as assigned.- Lead/ Support department Initiatives- In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.**Qualifications**- Bachelor’s degree in Life sciences or a related field (mandatory)- Fluency in English and French (mandatory)- 1 year of pharmacovigilance experience will be highly valued100% home-based role

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