Submission Reviewer
Company Name:-
IQVIA
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Job Overview
Review, 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 FunctionsTo 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 informationdetermining initial/update status of incoming eventsdatabase entrycoding 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 managementhealth 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 Initiatives100% compliance towards all people practices and processes
QualificationsHigh School Diploma or equiva
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