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PADER Aggregate Report Specialist

4 - 6 years

1 - 4 Lacs

Hyderabad

Posted:4 months ago| Platform: Naukri logo

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Skills Required

Training Compliance GCP Archiving Manager Quality Control Quality Review Auditing ICH

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are seeking a skilled PADER Aggregate Report Specialist with expertise in drafting, reviewing, and submitting PADER reports in compliance with regulatory requirements.

Key Responsibilities:


  1. Draft PADER aggregate reports as per the aggregate reporting schedule.
  2. Prepare line listings and tabulations for inclusion in the PADER report.
  3. Develop and maintain the PADER report calendar and schedule.
  4. Coordinate and resolve queries with cross-functional teams before finalizing line listings, addressing any issues identified in draft cases.
  5. Communicate with cross-functional teams to obtain required inputs and resolve queries efficiently.
  6. Archive all PADER-related information in the designated shared drive.
  7. Submit PADER documents and reports within specified timelines, ensuring compliance with internal and regulatory submission requirements.
  8. Prepare and review SOPs and work instructions in alignment with ICH-GCP, GVP modules, and FDA guidelines.
  9. Provide training to junior associates on PADER report preparation and processes.
  10. Support client audits and regulatory authority inspections as needed.

Experience Required:

  • 4-6 years of experience in aggregate report preparation for quality control roles.
  • 3-4 years of experience in aggregate report drafting roles.

Educational Qualifications:

  • M.Pharm or Pharm.D candidates are preferred.

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