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The Sr Specialist is responsible for quality review and compliance monitoring of aggregate safety reports, ensuring they adhere to regulatory requirements. This role entails calculating patient exposure, tracking metrics, collaborating with stakeholders to address quality issues, and maintaining procedural documents relevant to compliance. The specialist participates in inspection readiness activities and contributes to process improvements.

The Senior Specialist PV Case Exchange will manage submissions, generate reports, liaise with internal teams and regulatory authorities, and ensure compliance with submission standards. Responsibilities include monitoring submission queries, resolving electronic submission issues, and maintaining acknowledgment files for clinical trial reports. The role involves collaboration across departments and supports quality documentation and audits.

The role involves providing clinical information and support to healthcare providers, achieving sales targets, managing lead generation, and ensuring customer satisfaction through effective communication and problem-solving.