Description
As a Project Manager, Safety Aggregate Reports, you will lead the preparation and submission of safety aggregate reports to regulatory bodies such as the FDA and EMA.
You will partner with various teams including safety, clinical, regulatory, and others to ensure timely completion of reports while maintaining regulatory compliance.
Key responsibilities include:
- Leading report preparation from inception to submission with stakeholders from Clinical, Regulatory, Safety, and other departments.
- Reviewing data for consistency across various contributors.
- Compiling report information using electronic tools and document management systems.
- Coordinating review and approval processes, addressing comments, and ensuring reports meet regulatory deadlines.
- Providing guidance to contributors on report requirements and participating in projects or tasks supporting the group's deliverables.
- Participating in User Acceptance Testing (UAT) as needed and completing required training under Pfizer's and WSR Safety Information Management curriculum.
Technical skills required include experience with Microsoft products (Word, PowerPoint, Excel, Outlook, Teams), SharePoint technology, and PDF software (e.g., Adobe). Business Objects/Business Intelligence experience is advantageous.
Qualifications include a Bachelor's degree in life sciences, healthcare, or a pharmaceutical discipline. Experience in the pharmaceutical industry, clinical research, or a related field is preferred. Excellent English communication and presentation skills, attention to detail, strong project management, and issue resolution skills are necessary. Knowledge of regulatory/safety regulations and guidelines is desirable.
In terms of compensation, the minimal annual gross base salary is 100,500 PLN, with an annual bonus of 10%. Benefits include Medicover, MultiSport, UNIQUA, PPE, and others as per Pfizer's Pay Policy.