Senior Pharmacovigilance Specialist

About the role

Bell Trans is a globally focused organization dedicated to patient safety and the compliant use of medicines. The Senior Pharmacovigilance Specialist will lead and support a wide range of pharmacovigilance activities, ensuring safety information is accurately assessed, documented, and reported across diverse markets.

Key responsibilities

• Manage pharmacovigilance activities for assigned products, including case intake, assessment, coding, narrative development, and regulatory reporting.
• Conduct safety surveillance, signal detection, and trend analysis to identify emerging safety concerns.
• Prepare and review aggregate safety reports such as PSURs, PBRERs, and Development Safety Update Reports.
• Collaborate with Regulatory Affairs, Medical Affairs, and external partners on safety submissions, inspections, and compliance activities.
• Support quality assurance, corrective actions, and continuous improvement of pharmacovigilance processes and systems.

Required skills

• MedDRA coding
• Individual case safety report processing
• Drug safety and adverse‑event assessment
• Regulatory safety operations and surveillance
• Medicinal‑product coding and pharmacovigilance analytics