Drug Safety Specialist

About the role

Avance Clinical is seeking a Drug Safety Specialist to provide safety reporting and management services for assigned clinical projects. You will ensure compliance with study protocols, SOPs, ICH GCP guidelines, and relevant regulatory requirements.

Key responsibilities

• Receive, assess, process, and track safety‑related events (SAEs, EIU reports, Events of Special Interest) from study sites.
• Generate concise case narratives in collaboration with the Medical Monitor and sponsor representatives.
• Create, modify, and review study‑specific Safety Reporting Plans (SRPs) as required.
• Participate in study kick‑off meetings and act as Lead Safety Officer for assigned projects.
• Ensure timely reporting, filing, and distribution of safety information.

Required profile

• Ordinary degree in a life‑science discipline.
• Minimum 2 years experience in safety/pharmacovigilance or a related combination of pharma/CRO experience.
• Minimum 4 years experience working in a GCP environment within the pharmaceutical or CRO sector.
• Formal, current ICH GCP training.
• Strong knowledge of Australian regulatory and EC clinical‑trial safety reporting requirements.
• Excellent oral and written communication skills for interaction with clients and senior management.

Required skills

• MedDRA coding
• WHO Drug coding
• ICH GCP compliance
• DSUR preparation (advantageous)
• Literature review
• Australian regulatory safety reporting
• EC clinical‑trial safety reporting

What we offer

• Friendly, collaborative work environment
• Culture that values honesty, respect, and teamwork
• Opportunities to work on diverse clinical studies