Senior Pharmacovigilance Specialist – Regulatory Intelligence & Submissions

About the role

ProPharma is seeking a Senior Pharmacovigilance Specialist to lead regulatory intelligence and safety submission activities across global markets. The role combines hands‑on management of Individual Case Safety Report (ICSR) submissions with oversight of periodic safety reporting, xEVMPD filings and system testing.

Key responsibilities

• Manage expedited and non‑expedited ICSR submissions, ensure compliance with global PV reporting requirements and conduct monthly reconciliation with clients and safety partners.
• Generate Argus‑based line listings, summary tabulations and coordinate periodic safety report submissions in accordance with local regulations.
• Research, collect and maintain up‑to‑date pharmacovigilance reporting requirements, perform monthly regulatory surveillance and support intelligence tools and ad‑hoc queries.
• Perform Performance Qualification testing for Oracle Argus upgrades, support E2B profile implementations and participate in data‑migration testing.
• Prepare, review and maintain xEVMPD submissions, updates and bulk changes within required timelines.

Required profile

• Minimum three years of experience working with pharmacovigilance safety databases and ICSR submissions.
• High school diploma required; post‑secondary education in life sciences preferred.
• Demonstrated ability to work independently and collaborate with cross‑functional global teams.

Required skills

• Oracle Argus Safety (or similar safety database) proficiency.
• Microsoft Office suite – Outlook, Word and Excel.
• Knowledge of E2B exchange standards and xEVMPD requirements.

What we offer

• Opportunity to work with a global team of PV and regulatory experts.
• Exposure to international safety reporting requirements and health‑authority interactions.
• Involvement in projects that directly support patient safety and regulatory compliance worldwide.
• Hybrid work model with flexibility for remote and on‑site collaboration.