Pfizer Jobs; Aggregate Report Coordinator Job Opportunities For All Life Sciences Candidates

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Pfizer is seeking an Aggregate Report Coordinator for its team in Chennai, India. The position requires a Bachelor’s degree in life sciences, healthcare, or pharmaceutical discipline, excellent communication and presentation skills, and attention to detail.

Job description; The coordinator will be responsible for project management of safety aggregate reports, partnering with colleagues from various functional lines to produce reports and ensure regulatory compliance. The role involves leading report preparation, reviewing data, compiling information, coordinating reviews and approvals, and guiding contributors. The coordinator will also participate in developing and performing user acceptance testing and completing required training.

Associate – Aggregate Report Coordinator

locations; India – Chennai

time type; Full time

job requisition id; 4882350

Position Purpose

  • The individuals filling the position are responsible for the project management of safety aggregate reports submitted to regulators, including 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 promptly, 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 systems.
    • Coordinate the review and approval of the report and address review comments.
    • Ensure reports are completed before the regulatory due date to meet compliance.
    • Guide 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 by 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 and written communication and presentation skills are required.
      • Must be detail-oriented.
      • Strong project management and issue resolution skills are required.
      • Demonstrated ability to perform in a cross-functional environment.
      • Knowledge of regulatory/safety regulations and guidelines desired.

      Work Location Assignment: Flexible

      Work Location Assignment: Flexible

      Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction.

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