Lead Argus Reporting Manager

As a Lead Argus Reporting Manager at MEDTEK AI, you will be responsible for overseeing global pharmacovigilance regulatory reporting activities using Oracle Argus Safety. Your role will involve ensuring timely and compliant submission of safety reports, leading reporting teams, and serving as a subject matter expert for Argus reporting processes. Key Responsibilities: - Manage a team of ARGUS and dashboard developers. - Coordinate work and priorities with stakeholders. - Write complex queries in ARGUS to generate adhoc reports. - Generate reports for DSUR, PSUR, and other adhoc regulatory filings. - Perform quality checks, documentation, and resolve any gaps. - Demonstrate the ability to manage competing priorities and possess excellent project management skills. - Lead and manage regulatory safety reporting using Argus Safety. - Ensure compliance with global PV regulations (FDA, EMA, E2B, etc.). - Deliver all reports on time without any quality issues. - Act as a subject matter expert for Argus reporting workflows and E2B submissions. Qualifications: - Bachelor's degree in Life Sciences or related field. - 7+ years of pharmacovigilance experience. - 6+ years of hands-on Argus Safety reporting experience. - Strong knowledge of global regulatory reporting requirements. At MEDTEK AI, we are a data science-driven company focused on accelerating drug development and healthcare solutions. Our team comprises senior statisticians, data scientists, statistical modeling and programming experts, data visualization specialists, cloud data engineers, data lake strategists, regulatory submission experts, and drug safety consultants. We deliver support to pharmaceutical and biotech companies across North America, Japan, and the European Union. Our mission is to innovate and provide cutting-edge solutions for the healthcare and pharmaceutical industries. As a Lead Argus Reporting Manager at MEDTEK AI, you will be responsible for overseeing global pharmacovigilance regulatory reporting activities using Oracle Argus Safety. Your role will involve ensuring timely and compliant submission of safety reports, leading reporting teams, and serving as a subject matter expert for Argus reporting processes. Key Responsibilities: - Manage a team of ARGUS and dashboard developers. - Coordinate work and priorities with stakeholders. - Write complex queries in ARGUS to generate adhoc reports. - Generate reports for DSUR, PSUR, and other adhoc regulatory filings. - Perform quality checks, documentation, and resolve any gaps. - Demonstrate the ability to manage competing priorities and possess excellent project management skills. - Lead and manage regulatory safety reporting using Argus Safety. - Ensure compliance with global PV regulations (FDA, EMA, E2B, etc.). - Deliver all reports on time without any quality issues. - Act as a subject matter expert for Argus reporting workflows and E2B submissions. Qualifications: - Bachelor's degree in Life Sciences or related field. - 7+ years of pharmacovigilance experience. - 6+ years of hands-on Argus Safety reporting experience. - Strong knowledge of global regulatory reporting requirements. At MEDTEK AI, we are a data science-driven company focused on accelerating drug development and healthcare solutions. Our team comprises senior statisticians, data scientists, statistical modeling and programming experts, data visualization specialists, cloud data engineers, data lake strategists, regulatory submission experts, and drug safety consultants. We deliver support to pharmaceutical and biotech companies across North America, Japan, and the European Union. Our mission is to innovate and provide cutting-edge solutions for the healthcare and pharmaceutical industries.