Senior Safety Committee Specialist – Adjudication

About the role

We are seeking a Senior Safety Committee Specialist to lead complex safety projects, collaborate with global teams, and ensure the successful implementation of pharmacovigilance practices. The role focuses on CEC/DSMB study start‑up, execution, and close‑out activities, contributing to the safety and efficacy of our products.

Key responsibilities

• Develop charters, contract committee members, and build electronic adjudication systems for CEC/DSMB studies.
• Act as liaison between the company, sponsors, and project teams for CEC/DSMB strategy execution.
• Perform day‑to‑day CEC/DSMB activities, maintain secure files for unblinded data, and ensure compliance with procedural documents.
• Review adjudication publications, stay updated on regulations, and maintain therapeutic area knowledge.
• Prepare and quality‑check CEC dossiers, support project implementation, and represent the committee in audits and meetings.

Required profile

• Bachelor’s degree or equivalent with at least 5 years of relevant experience.
• Strong understanding of pathophysiology, disease processes, and therapeutic areas relevant to CEC/DSMB review.
• Excellent critical‑thinking, problem‑solving, and communication skills.
• Ability to work independently, prioritize tasks, and meet strict deadlines.

Required skills

• Proficiency with Microsoft Outlook, Word, and Excel.
• Computer literacy and experience working with multiple databases.
• Thorough knowledge of procedural compliance and regulatory requirements.