Senior Pharmacovigilance Specialist, Regulatory Intelligence and Submissions

About the role

ProPharma is seeking a detail‑oriented Senior Pharmacovigilance Specialist to lead regulatory intelligence and safety submissions across global markets. You will ensure timely, compliant reporting while supporting continuous improvement of PV systems.

Key responsibilities

• Manage and monitor expedited and non‑expedited Individual Case Safety Report (ICSR) submissions and exchanges.
• Generate Argus‑based line listings and summary tabulations for periodic safety reports.
• Research, collect, and maintain global pharmacovigilance reporting requirements for pharmaceuticals, biologics, and medical devices.
• Perform Performance Qualification testing for Argus upgrades, patches, and custom developments.
• Prepare and maintain xEVMPD submissions, updates, removals, and new product entries within required timelines.

Required profile

• High school diploma required; post‑secondary education in a life‑sciences discipline preferred.
• Minimum 3 years experience working with pharmacovigilance safety databases and ICSR submissions.
• Experience with Oracle Argus Safety or similar safety databases is highly desirable.

Required skills

• Oracle Argus Safety (or comparable safety database).
• Microsoft Outlook, Word and Excel.

What we offer

• Work with a global team of pharmacovigilance and regulatory experts.
• Gain exposure to international safety reporting requirements and health‑authority interactions.
• Contribute to projects that support patient safety and regulatory compliance worldwide.
• Develop expertise across submissions, regulatory intelligence, testing, and PV systems in a dynamic environment.