Pfizer

Report Coordinator Associate

Posted An Hour Ago

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2 Locations

Hybrid

Junior

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Manage end-to-end preparation and submission of safety aggregate reports for regulators (FDA, EMA). Coordinate cross-functional contributors, compile and review data, manage approvals and review comments, ensure regulatory deadlines and compliance, support UAT, and complete required safety information management training.

Summary Generated by Built In

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.
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.

Technical Skill Requirements
Experience with:

Microsoft Products, (e.g., Word, PowerPoint, Excel, Outlook, Teams)
SharePoint technology
PDF software (e.g., Adobe)

Business Objects/Business Intelligence experience is a plus.
Qualifications (i.e., preferred education, experience, attributes)

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.

Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical

Skills Required

Bachelor's degree in life sciences, healthcare, or pharmaceutical discipline
Experience with Microsoft Word, PowerPoint, Excel, Outlook, Teams
Experience with SharePoint
Experience with PDF software (e.g., Adobe)
Experience in the pharmaceutical industry, clinical research, or healthcare related field
Excellent English verbal, written communication and presentation skills
Detail oriented
Strong project management and issue resolution skills
Demonstrated ability to perform in a cross-functional environment
Knowledge of regulatory/safety regulations and guidelines
Business Objects / Business Intelligence experience
Experience participating in User Acceptance Testing (UAT)

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Healthcare Strength — Health coverage includes comprehensive medical with robust mental‑health networks, plus dental and vision options, and coverage for infertility/family‑building and transgender‑affirming care. Recent U.S. summaries name mental‑health partners and outline multiple plan choices.
Retirement Support — The retirement program provides a 401(k) with company match plus an additional employer Retirement Savings Contribution, along with financial‑planning support and company‑paid life and disability insurance. These elements are highlighted as part of the core U.S. package.
Parental & Family Support — Parental leave is described as up to 26 weeks in the U.S. when combining paid non‑medical parental leave with medical recovery where applicable, with exact pay and weeks dependent on circumstances and plan elections. Family‑building support includes egg preservation, adoption, and surrogacy coverage.

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.