Drug Device Safety Officer II

About the role

Premier Research is seeking a Drug Device Safety Officer II to join its Pharmacovigilance and Records Management team. The role supports biotech, medtech and specialty pharma clients by ensuring safety data compliance, managing serious adverse events (SAEs), and contributing to regulatory submissions.

Key responsibilities

• Ensure compliance with international standards (ICH GCP, ICH E2A), national regulations and project‑specific SOPs.
• Review incoming SAEs for accuracy, completeness and potential safety issues, and draft narratives as required.
• Enter safety data into the safety database and manage SAE processing for roughly 80% of billable time.
• Collaborate with investigators, CRAs, Data Managers, Medical Directors and Medical Monitors during AE/SAE reconciliation and reporting.
• Prepare draft Safety Management Plans, periodic safety reports (DSURs, ASRs) and support audit/inspection activities.
• Perform quality checks of SAE entries, maintain eTMF filing, and submit SAE/SUSARs via platforms such as Eudravigilance and Toetsing online.
• Mentor and train new team members.

Required profile

• Bachelor’s degree in medicine, nursing, pharmacy, life sciences or related field; advanced degree preferred.
• 2–4 years of experience in a medical safety department with hands‑on case processing and safety database usage.
• Fluent written and spoken English and the local language(s).
• Strong organizational, multitasking and communication abilities in a fast‑paced environment.

Required skills

• Proficiency with safety databases such as Argus (AERS/ARISg).
• Knowledge of ICH/GCP regulations, FDA guidance documents, EU directives and ISO 14155.
• Experience with electronic Trial Master File (eTMF) systems.
• Familiarity with web‑based communication tools for conference calls.
• Ability to submit safety reports using platforms like Eudravigilance and Toetsing online.