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Aggregate Report Coordinator

2+ years
Not Disclosed
10 July 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Purpose: The role involves project management of safety aggregate reports submitted to regulators such as the FDA and EMA. The individual will collaborate with colleagues from various departments including safety, clinical, regulatory, and others to produce these reports, ensuring timely completion and regulatory compliance.

Primary Responsibilities:

  • Lead the preparation of reports, from initial stages to submission, coordinating with key stakeholders in Clinical, Regulatory, Safety, DevOps, and Submissions.
  • Review data for consistency across contributors.
  • Compile report information using electronic tools and document management systems.
  • Manage the review and approval process, addressing feedback and ensuring reports are finalized before regulatory deadlines.
  • Provide guidance to contributors on report requirements.
  • Participate in projects or tasks supporting the group’s deliverables.
  • Participate in developing and conducting User Acceptance Testing (UAT) as needed.
  • Complete training as per Pfizer’s and WSR Safety Information Management curriculum.

Technical Skill Requirements:

  • Experience in the pharmaceutical industry, clinical research, or a healthcare-related field.
  • Proficiency in Microsoft Word & Excel, Adobe Acrobat, and ISI Toolbox.
  • Experience with SharePoint technology (e.g., Microsoft InfoPath, SharePoint Designer).
  • Experience with Business Objects is a plus.

Qualifications:

  • Bachelor’s Degree in life sciences, healthcare, or pharmaceutical discipline.
  • Excellent English verbal, written communication, and presentation skills.
  • Detail-oriented with strong project management and issue resolution skills.
  • Ability to work effectively in a cross-functional environment.
  • Knowledge of regulatory/safety regulations and guidelines is preferred.

Work Location Assignment: Flexible

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