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 Australian regulatory requirements.

Key responsibilities

• Receive, assess, process and track safety events (SAEs, EIU reports, Events of Special Interest) from study sites.
• Generate concise case narratives and liaise with Medical Monitor and Sponsor representatives.
• Create, modify and review study‑specific Safety Reporting Plans (SRPs) in line with contractual arrangements.
• Participate in study kick‑off meetings and act as Lead Safety Officer overseeing regulatory compliance.
• Ensure timely reporting, tracking, filing and distribution of safety information.

Required profile

• Ordinary degree in a life‑science discipline.
• Minimum 2 years experience in safety/pharmacovigilance and at least 4 years in a GCP‑compliant pharmaceutical or CRO environment.
• Formal ICH GCP training and sound knowledge of Australian clinical trial safety reporting requirements.
• Ability to communicate effectively with clients, senior management and multidisciplinary teams.

Required skills

• MedDRA and WHO Drug coding.
• DSUR preparation (advantageous).
• Literature review.
• Proficiency in MS Word and Excel (intermediate to advanced).
• Experience with safety/pharmacovigilance databases (desirable).

What we offer

• Stimulating, diverse projects with intellectual challenge.
• Agile, flexible workplace and remote work options.
• Opportunities for career progression and stability.
• Community‑focused culture with leadership alignment.
• Competitive salary and an extra day off for your birthday.