Company Description

MEDTEK AI is 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.

Job Summary

We are seeking a Lead Argus Reporting Manager to oversee global pharmacovigilance regulatory reporting activities using Oracle Argus Safety. This role ensures timely and compliant submission of safety reports, leads reporting teams, and serves as a subject matter expert for Argus reporting processes.

Key Responsibilities

·      Manage team of ARGUS and dashboard developer.

·      Coordinate work and priorities with stake holders

·      Write complex Queries in ARGUS to generate adhoc reports

·      Generate report for DSUR, PSUR and other adhoc regulatory filings.

·      Perform quality checks, documentation and resolve any gaps

·      Able to manage competing priorities and have an 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 SME 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