Senior Patient Safety Specialist

About the role

The Senior Patient Safety Specialist will lead safety activities across global pharmacovigilance projects, ensuring compliance with regulatory requirements and driving continuous improvement in safety data management.

Key responsibilities

• Maintain expert‑level knowledge of safety profiles, labeling, and global regulations.
• Lead development of project‑specific safety procedures, workflows, and database setups.
• Provide technical guidance to junior team members and coordinate cross‑functional safety deliverables.
• Manage ICSR processing, case assessment, documentation, and quality control.
• Prepare and execute safety submissions, portal/gateway setups, and unblinding procedures.
• Develop and maintain literature search strategies, screen publications for safety signals, and support signal detection.
• Serve as primary liaison between global safety operations and local affiliates, ensuring local regulatory compliance.
• Support audits, inspections, and quality assurance activities, and represent the team in client or investigator meetings.

Required profile

• Extensive experience in pharmacovigilance, drug safety, or related regulatory affairs.
• Proven ability to lead safety projects and mentor junior staff.
• Strong analytical skills with a focus on continuous improvement.
• Excellent communication and stakeholder management capabilities.

Required skills

• ICSR processing and case assessment
• Regulatory reporting and safety submissions
• Safety data management and quality assurance
• Literature search and signal detection
• Pharmacovigilance regulations (EMA, FDA, ICH)