Pfizer Hiring Freshers in Pharmacovigilance as Aggregate Report Coordinator
About Company
The Aggregate Report Coordinator manages the project lifecycle of safety aggregate reports submitted to regulatory bodies like the FDA and EMA. This role involves collaborating with colleagues from various departments including safety, clinical, regulatory, and other functional lines to produce timely and compliant aggregate reports.
Position Details
| Position Name | Aggregate Report Coordinator |
|---|---|
| Organization | Pfizer |
| Qualification | B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences |
| Experience | 0 Years / Freshers – 1 Year |
| Salary | ₹25,000 – ₹35,000 per month |
| Location | Chennai |
Primary Responsibilities
- Report Management: Lead preparation, review, and submission of safety aggregate reports, coordinating with key stakeholders across Clinical, Regulatory, Safety, DevOps, Submissions, etc.
- Data Consistency: Ensure consistency of data provided by various contributors.
- Compilation and Documentation: Compile information using electronic tools and document management systems.
- Review Coordination: Oversee the review and approval process of reports, addressing comments as necessary.
- Compliance: Ensure reports are completed and submitted by regulatory due dates.
- Guidance and Support: Provide guidance to contributors on report requirements.
- Project Participation: Engage in projects or subject matter tasks that support the group’s objectives.
- User Acceptance Testing (UAT): Participate in developing and performing UAT as needed.
- Training: Complete training according to Pfizer’s and WSR Safety Information Management curriculum