Safety Aggregate Report Coordinator Associate

Pfizer; Polska; Hybrid; PLN 90,000 - 111,000; Full time

Benefits offered by this job

Medicover

MultiSport

UNIQUA

PPE at Goldman Sachs and other

Job summary

Pfizer in Warsaw, Poland, is seeking an experienced project manager to lead safety aggregate report preparation for regulatory submissions (FDA/EMA). You will coordinate cross-functional teams across Clinical, Regulatory, Safety, and other lines to ensure timely, compliant reports and provide guidance on report requirements.

The role requires strong English communication, a detail-oriented mindset, and solid project management skills.

Qualifications

• Bachelor's 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.

Responsibilities

• Lead report preparation from prep to submission with key stakeholders 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 developing and performing User Acceptance Testing (UAT) as required.

Skills

Project management

Cross-functional collaboration

Communication

Microsoft Office

Education

Bachelor's Degree in life sciences/healthcare/pharmaceutical

Tools

SharePoint

PDF software (Adobe)

Business Objects/BI

Job description

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.

Purpose

Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

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 [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interview