Drug Safety Administrator

About the role

The Drug Safety Administrator will support the Pharmacovigilance team by managing safety case reports, monitoring literature, and ensuring compliance with quality and regulatory standards. This position is suitable for recent graduates or candidates with up to one year of relevant experience.

Key responsibilities

• Upload ProQuest alerts for assigned active ingredients into the Literature Monitoring System (LMS).
• Identify and process case reports and important safety information from the LMS database.
• Enter and code case reports in the ICSR database, ensuring correct MedDRA terms are applied.
• Notify the QPPV when MedDRA terms cannot be identified independently.
• Reconcile safety data with clients and pharmacovigilance partners as required.
• Screen published literature and manage individual case safety reports.
• Attach source documents to each case in the drug safety database.
• Conduct follow‑up investigations for reports received from patients or healthcare professionals.

Required profile

• Life Science degree, pharmacy degree, or nursing qualification.
• At least 1 year of experience as a Drug Safety Administrator or a recent graduate.
• Understanding of Quality Management Processes and relevant company policies.
• Ability to escalate complex cases to senior staff when needed.

Required skills

• MedDRA coding
• ICSR database management
• Literature Monitoring System (LMS) usage
• ProQuest alerts handling
• Pharmacovigilance case processing