Position Purpose

Conducts and manages Aggregate Safety Report QC activities (PADER, PBRER, DSUR etc) produced by the Aggregate Report Center of Excellence (CoE) to ensure accuracy, internal consistency, uniformity and compliance with global aggregate reporting commitments.

Primary Responsibilities

• Support the Aggregate Report CoE by participating in and/or leading peer QC activities, set the standard for enhanced collaboration, and deliver project commitments.
• Plans, designs and participate independently, as appropriate, in the ongoing review and QC of a designated report's safety information.
• Participates on project teams, task forces and/or working groups to identify opportunities for peer QC process improvement initiatives.
• Manages special projects and senior management requests associated with peer QC compliance, as needed.
• Serve as a Peer QC Subject Matter Expert (SME) on training, knowledge sharing, technology, or specific work processes, providing advice and guidance as appropriate.
• Collection of peer QC metric data for analysis.
• Support regulatory inspections, internal audits and/or strategic quality initiatives.

• Strategic Thinking with demonstrated ability to understand and consider competitive positioning when solving problems and making decisions.
• Demonstrated knowledge of safety, clinical and/or regulatory.
• Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies.
• Demonstrated ability to manage complex projects and cross-functional processes and to meet established deadlines.
• Demonstrated ability to effectively work on simultaneous complex projects/deliverables.
• Demonstrated analytical and statistical skills.
• Thorough understanding of system technologies that support the business. Can apply technical and line knowledge of key concepts and may act as a resource.

• BS degree (or equivalent). A scientific or technical degree is preferred.

• Prefers > 1 years' experience in clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry.
• Familiarity with case processing (ICSR) and aggregate reports like PADER and PBRER is preferred.
• Experience in quality control and/or quality assurance within the pharmaceutical industry preferred.
• Knowledge of global safety regulations and guidelines, or equivalent.
• Demonstrated computer literacy, particularly in the use and management of relational databases.
• Demonstrated strength in analytical skills and attention to detail.
• Demonstrated organizational/project management skills.
• Demonstrated strength in oral/written communication and interpersonal skills.
• Ability to make decisions independently and resolve issues appropriately.
• Innovative and strategic thinking.