Senior Pharmacovigilance Specialist – Regulatory Intelligence & Submissions

About the role

ProPharma is seeking a detail‑oriented Senior Pharmacovigilance Specialist to lead regulatory intelligence and global safety submissions. You will ensure timely, compliant reporting and support continuous improvement of PV systems in a fast‑paced, international environment.

Key responsibilities

• Manage expedited and non‑expedited ICSR submissions, conduct monthly reconciliations and support gateway‑to‑gateway testing.
• Generate Argus‑based line listings, create and validate periodic safety reports, and coordinate submissions across global markets.
• Research and maintain up‑to‑date PV reporting requirements, conduct monthly regulatory surveillance, and respond to queries.
• Perform PQ testing for Argus upgrades, support E2B profile implementations, and participate in data migration testing.
• Prepare, review and maintain xEVMPD submissions, including bulk updates and QPPV changes.

Required profile

• Minimum 3 years of experience with pharmacovigilance safety databases and ICSR reporting.
• High school diploma required; post‑secondary life‑science education preferred.
• Strong attention to detail, excellent communication skills and ability to manage multiple priorities.

Required skills

• Oracle Argus Safety (or similar safety database) proficiency.
• Knowledge of xEVMPD and global PV regulations.
• Advanced use of Microsoft Office applications (Outlook, Word, Excel).

What we offer

• Work with a global team of PV and regulatory experts.
• Exposure to international safety reporting requirements and health‑authority interactions.
• Opportunities to develop expertise across submissions, regulatory intelligence, testing and PV systems.
• Hybrid work model with flexibility for remote and on‑site collaboration.