• Aggregate Report Coordinator Jobs in Philippines

  • Pfizer Inc.
  • Philippines
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

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 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 Pfizers and WSR Safety information Management curriculum

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 (eg, Microsoft InfoPath, SharePoint Designer, etc)
Business Objects experience is a plus
Bachelors 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 Job Title
Aggregate Report Management (ARM), Report Coordinator I

Organization

Worldwide Research & Development (WRD) / Worldwide Safety and Regulatory (WSR)

Line

Safety Evaluation and Reporting (SER)

Department/Group (if applicable)

Product Safety Surveillance and Reporting (PSSR) Center of Excellence (CoE)

Region and/or Country (if applicable)

N/A

Version Date

13-Mar-2019

Organizational Relationship(s) including to whom the position reports (JD Job Title)

Aggregate Report Coordination Team Lead

Position Purpose

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

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
Complete training in accordance with Pfizers 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 (eg, Microsoft InfoPath, SharePoint Designer, etc)
Business Objects experience is a plus

Qualifications (ie, preferred education, experience, attributes)

Bachelors 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
Knowledge of FDA, EMEA and ICH regulations is preferred

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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 15th Mar 2020

Key Skills:

Company Profile:

Company
Pfizer Incarfix

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