Job Description
Job Overview
Essential Functions
- 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, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
- Perform activities related to adjudication as applicable
- Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legi...
Essential Functions
- 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, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
- Perform activities related to adjudication as applicable
- Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legi...
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