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…