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Manager - Pharmacovigilance Department

  • Date Posted February 14, 2020
  • Location Hyderabad
  • Job Title Manager - Pharmacovigilance Department
  • Job ID JS-PV-456
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Job Desciption

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

Location: Hyderabad

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