hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Aggregate Report Coordinator

1.00 to 2.00 Years   Chennai   08 Feb, 2021
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD,Quality (QA-QC)
EmploymentTypeFull-time

Job Description

Position PurposeIndividual 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.Primary Responsibilities

  • 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 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.
Technical Skill Requirements
  • Experience in the pharmaceutical industry, clinical research, or healthcare related field.
  • Experience with Microsoft word & excel, Adobe acrobat, ISI Toolbox, etc.
  • Experience with SharePoint technology (e.g., Microsoft InfoPath, SharePoint Designer, etc.)
  • Business Objects experience is a plus.
Qualifications(i.e., preferred education, experience, attributes)
  • Bachelor s Degree in life sciences, healthcare, or pharmaceutical discipline required.
  • 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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical #LI-PFE,

Keyskills :
user acceptance testingisi toolboxadobe acrobatmicrosoft worduser acceptanceissue resolutionclinical researchproject managementacceptance testingreport preparationdocument managementsharepoint designer

APPLY NOW

Aggregate Report Coordinator Related Jobs

© 2019 Hireejobs All Rights Reserved