Pharmacovigilance Specialist Ssr/Sr

Detalles de la oferta

.Job OverviewReview, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.**Essential Functions**- To Prioritize and complete the assigned trainings on time.- Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.- To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events (AE)/endpoint information- determining initial/update status of incoming events- database entry- coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.- Ensure to meet quality standards per project requirements.- Ensure to meet productivity and delivery standards per project requirements.- To ensure compliance to all project related processes and activities.- 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.- Creating, maintaining, and tracking cases as applicable to the project plan.- Identify quality problems, if any, and bring them to the attention of a senior team member.- To demonstrate problem solving capabilities.- 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.- Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.- Perform other duties as assigned.- Lead/ Support department Initiatives- 100% compliance towards all people practices and processes- 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


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

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