Safety Aggregate Report Coordinator Associate

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 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. 

  

Minimal annual gross base salary: 100.500 PLN
Annual Bonus: 10%
Benefits: Medicover, MultiSport, UNIQUA, PPE at Goldman Sachs and other, as per Pfizer Pay Policy
Work Location Assignment: Hybrid

The annual base salary for this position ranges from zł100.500,00. This salary range applies to the location Poland - Warsaw. We also offer a range of benefits and programs to meet colleagues’ needs. Benefits vary by location and can include health care coverage, retirement savings plans, insurance benefits, an Employee Assistance Program, wellness benefits and more. Additional details about total compensation and benefits will be provided during the hiring process. Pfizer compensation structures and benefit packages are aligned based on the location of hire. Final compensation will be determined based on the successful candidate’s relevant skills, experience, and qualifications, in accordance with pay equity principles and applicable employment laws.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address sygnalisci-px@pfizer.com.

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