Safety Aggregate Report Coordinator Associate

Pfizer Inc; Warszawa; Hybrid; PLN 90,000 - 111,000; Full time

Benefits offered by this job

Medicover

MultiSport

UNIQUA

Pfizer Pay Policy

Job summary

Pfizer Inc in Warsaw, Poland is seeking a Safety Aggregate Report Coordinator Associate to manage regulatory aggregate report submissions. You will coordinate cross-functional teams across safety, clinical, regulatory, and DevOps to ensure timely, compliant reports.

Responsibilities include leading report prep, data review for consistency, and coordinating review and approval, with emphasis on meeting due dates and regulatory expectations. Hybrid work arrangement offered.

Qualifications

• Bachelor’s Degree in life sciences, healthcare, or pharmaceutical discipline required.
• Experience in the pharmaceutical industry, clinical research, or healthcare related field preferred.
• Excellent English verbal, written communication and presentation skills required.
• Must be detailed oriented.
• Strong project management and issue resolution skills.
• Demonstrated ability to work in a cross-functional environment.
• Knowledge of regulatory/safety regulations and guidelines desired.

Responsibilities

• Lead report preparation from prep to submission with key stakeholders within Clinical, Regulatory, Safety, DevOps, Submissions, etc.
• Review data to ensure consistency between 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 developing and performing User Acceptance Testing (UAT) as required.
• Complete training in accordance with Pfizer’s and WSR Safety information Management curriculum.

Skills

Attention to detail

Project management

Cross-functional collaboration

Regulatory knowledge

English communication

Education

Bachelor’s Degree in life sciences, healthcare, or pharmaceutical discipline

Tools

Microsoft Office

SharePoint

PDF software

Business Objects

Job description

Safety Aggregate Report Coordinator Associate### Safety Aggregate Report Coordinator AssociateApply: Poland - Warsaw: Full time: Posted Yesterday: 4966650**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:**HybridThe 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.