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.

Key responsibilities

• Develop charters, contract members, and build electronic adjudication systems for CEC/DSMB studies.
• Act as liaison between the company, sponsors, and project teams for CEC/DSMB strategies.
• Perform day‑to‑day CEC/DSMB activities, ensuring compliance with committee processes.
• Review adjudication and DSMB publications to stay current on regulations and best practices.
• Maintain medical understanding of therapeutic areas and disease states.
• Prepare and quality‑check CEC dossier compilations and submissions.
• Securely manage DSMB unblinded data files.
• Support routine project implementation, including presentations, metric reviews, and budget considerations.
• Assist in developing departmental procedures, attend audits, and represent CEC/DSMB functions at kick‑off and investigator meetings.

Required profile

• Bachelor’s degree or equivalent with at least 5 years of relevant experience.
• Strong understanding of pathophysiology and disease processes.
• Excellent critical‑thinking, problem‑solving, and communication skills.
• Proficiency in English with ability to translate information when required.
• Ability to manage multiple tasks, meet strict deadlines, and work independently.
• Professional demeanor and strong teamwork orientation.

Required skills

• Microsoft Office suite (Outlook, Word, Excel).
• Electronic adjudication system configuration and use.
• Database management and data security handling.