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 CEC/DSMB committees.
• Perform day‑to‑day CEC/DSMB activities, including dossier compilation, submission, and secure data handling.
• Review adjudication publications and stay updated on regulatory changes.
• Assist with project implementation, presentations, metric reviews, and budget considerations.
• Support audit preparation, kick‑off meetings, and investigator meetings representing CEC/DSMB functions.

Required profile

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

Required skills

• Proficiency in Microsoft Office suite (Outlook, Word, Excel).
• Computer literacy with experience using multiple databases.
• Thorough knowledge of procedural compliance and regulatory documentation.