Fidelity Health Services Hiring For Aggregate Report Writer/ Safety Writer

Fidelity Health Services Hiring For Aggregate Report Writer/ Safety Writer

Designation: Aggregate report writer/ Safety Writer

Qualification: M Pharm/ B. Pharm/ BAMS/ BHMS

Experience: Minimum 3-4 years of experience in preparation of aggregate reports and case processing.

Location: Mumbai

Preparing and maintaining the aggregate report planner to keep a track of the global aggregate report submission

Review various formats of aggregate reports like Periodic Adverse Drug Experience Report (PADER), Periodic Safety Update Report (PSUR), Periodic Benefit Evaluation Report (PBRER)

Collating data from various sources and having in-depth knowledge of the safety database.

Liase with cross functional teams to ensure all the required data are in place for the aggregate reports

Preparing and maintaining the aggregate report compliance tracker and ensuring compliance and ensuring appropriate corrective and preventive actions are in place for deviations if any.

Interested candidates can share CV on hr@fidelityhs.com

Fidelity Health Services Hiring For Aggregate Report Writer/ Safety Writer