PADER Aggrigate Report Authoring and Quality Review

Job Description:

Responsibilities

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

Qualification & Experience

• 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.