About the role
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.
ONLY CANDIDATES WITH RELEVANT EXPERIENCE SHOULD APPLY. APPLICATIONS FROM OTHERS WILL BE AUTOMATICALLY REJECTED
Key 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.
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.
If you meet the qualifications and are eager to contribute to a dynamic team, apply now!