Aggregate Report Management Scheduling Lead
United Kingdom - Sandwich
Italy - Milan
Oversees all aspects of creating, maintaining and implementing a comprehensive, dynamic and resource efficient calendar of safety aggregate report deliverables.
This includes, but is not limited to IND ARs, DSURs, PADERs, PAERs, PSURs and SUSAR LLs. This position negotiates safety submission commitments with Pfizer Country Offices and / or Regulatory, ensuring compliance needs are met while balancing resource effort to create submission documents;
interacts with requestors to resolve ad hoc report scheduling; and proposes assignments.
Creates and maintains the comprehensive safety aggregate report calendar.
Enters and assigns scheduled, and non-scheduled safety aggregate report deliverables.
Negotiates with appropriate groups (e.g. PCOs) to ensure that aggregate report commitments are met, while minimizing, the number of individual reports required, when possible, as well as developing schedules for new aggregate report types as required by regulations.
Participates in appropriate governance and policy meetings / groups. Is empowered to make independent decisions affecting the operations of the group.
Acts as subject matter expert on aggregate reports scheduling and represents this role on various teams and taskforces.
Acts as business subject matter expert for systems used for aggregate reports calendar (DocFlow) and the RMP assignment (Compass) and participates in various technology forums.
Design, implement, and report relevant aggregate reporting metrics.
Supports Audit / inspection requests.
Maintains License Partner aggregate report requests mailbox.
Technical Skill Requirements
Demonstrated ability to lead / manage and bring projects to successful completion while
simultaneously juggling multiple projects and processes that span globally.
General knowledge / understanding of technologies that can support Pfizer’s safety
submission work. Ability to adequately evaluate and leverage Pfizer’s system into improved
business processes to support business requirements.
Comprehensive working knowledge of requirement gathering, database design, and
Knowledge of clinical development and / or regulatory submission processes and
requirements. Knowledge of safety submission work, e.g. aggregate reporting requirements
Effective oral and written communication. Demonstrated ability to design, develop and
deliver effective presentations to key business units.
Scientific / technical academic background or equivalent, ideally with experience in the pharmaceutical industry, regulatory agency, or related field.
Understanding of clinical trials and drug development and comprehensive knowledge of the regulatory environment.
Strong understanding of safety and global regulatory reporting regulations and guidelines.
Comprehensive working knowledge and understanding of IT requirement gathering, database
structure, design and reporting tools.
Demonstrated ability to manage projects successfully, with minimal guidance.
Participates in appropriate governance and policy meetings / groups
Strong interpersonal skills with demonstrated ability to build relationships and influence
Extensive understanding of regulatory / safety regulations and guidelines and can
independently answer complex scheduling queries appropriately.
Strong project management and issue resolution skills.
Able to deliver effective presentations to key business units, as needed.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.