Senior Associate, Peer Qc Analyst

2 days ago

Chennai Tamil Nadu, India Pfizer Full time

Position PurposeConducts and manages Aggregate Safety Report QC activities PADER PSUR 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 reports 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 Technical Skill Requirements 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 Qualifications i e preferred education experience attributes Education BS degree or equivalent A scientific or technical degree is preferred Experience Prefers 2 years experience in clinical safety and or regulatory areas in the pharmaceutical healthcare industry Experience with aggregate reports like PADER or PSUR case processing ICSR or other relevant experience 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 Work Location Assignment Hybrid Work Location Assignment HybridPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates Quality Assurance and Control LI-PFE

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