Report Coordinator Associate
- Pfizer
- 1 - 4 years
- Chennai
- 10 days ago
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Job Description
- Individual filling the position are responsible for the project management of safety aggregate reports submitted to regulators that include the FDA and EMA.
- The incumbent will partner with various colleagues from Safety, Clinical, Regulatory and other functional lines to produce the aggregate reports and ensure that these reports are completed in a timely manner meeting regulatory compliance.
- Lead report preparation from prep to submission with key stakeholders/contributors within Clinical, Regulatory, Safety, DevOps, Submissions, etc.
- Review data to ensure consistency between various contributors.
- Compile the information for reports using various electronic tools and document management system.
- Coordinate the review and approval of the report and address review comments.
- Ensure reports are completed prior to regulatory due date to meet compliance.
- Provide guidance to contributor regarding report requirements.
- Participate in projects or subject matter tasks that support the group and deliverables.
- Participate in developing and performing User Acceptance Testing (UAT) as required.
- Complete training in accordance with Pfizer s and WSR Safety information Management curriculum.
- Microsoft Products, (e. g. , Word, PowerPoint, Excel, Outlook, Teams)
- SharePoint technology
- PDF software (e. g. , Adobe)
- Bachelor s Degree in life sciences, healthcare, or pharmaceutical discipline required.
- Experience in the pharmaceutical industry, clinical research, or healthcare related field is preferred.
- Excellent English verbal, written communication and presentation skills required.
- Must be detailed oriented.
- Strong project management and issue resolution skills required.
- Demonstrated ability to perform in a cross-functional environment.
- Knowledge of regulatory/safety regulations and guidelines desired.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: ConsultingRole Category: Management ConsultingRole: Associate / ConsultantEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Chennai
Keyskills: Business objects Project management Healthcare Clinical research Life sciences Information management Business intelligence microsoft Adobe User acceptance testing
Pfizer
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