JOB DESCRIPTION
Responsibilities:
Lead and manage the projects
Supervise all project related activities.
Communicate between the Project Manager and the team.
Record, maintain and track the metrics for both team members and project performance.
Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
Process current incoming cases in order to meet Regulatory timelines.
Provide guidance for Data entry.
Following up with sites regarding outstanding queries.
Follow-up on reconciliation discrepancies.
Follow departmental AE workflow procedures.
Train and mentor new team members as per requirements of the project.
To author/ draft aggregate reports/ quality reviewing like (PBRER/ PSURs, / PADER/ Addendum to Clinical Overviews) RMP and Signal detection experts
Experience: 7 – 10 years
Qualification: MBBS/MD/M.Pharm
Job ID : JS-PV-456
Location: Hyderabad