Core Responsibilities Include  

• Ensure receipt, assessment (initial and follow up), processing and tracking of safety-related events (SAEs, EIU reports or Events of Special Interest) from study sites in accordance with the CSP, applicable regulations, SOPs, study specific SRP and any other specific agreements related to the management of safety information for a clinical trial.
• Generate concise and accurate case narratives liaising with the study Medical Monitor and Sponsor Medical Representative(s) as required, in accordance with each study specific SRP and Client/Avance Clinical contractual arrangements.
• Create, modify and/or review study specific SRPs as required per project in accordance with the CSP and Client/Avance Clinical contractual arrangements.
• Participate in Study “Kick-Off” meetings with study project staff as required.
• Autonomously act as Lead Safety Officer and maintain oversight on regulatory compliance and status of safety-related services for assigned projects.
• Ensure timely reporting, tracking, filing and distribution

Qualifications, Skills and Experience  

• Ordinary Degree in a life science related discipline.
• Minimum of 2 years’ experience in a safety / pharmacovigilance role or relevant combination of pharmaceutical / CRO industry experience and qualifications.
• Minimum of 4 years’ experience in pharmaceutical industry / CRO working in a GCP environment.
• Experience in Literature review.
• Formal and current ICH GCP training.
• DSUR experience advantageous.
• Sound knowledge of Australian regulatory and EC Clinical trial safety reporting requirements
• Sound knowledge of MedDRA and WHO Drug coding.
• Ability to communicate at a high level with clients, senior management and other stakeholders.
• Excellent oral and written communications skills including the ability to liaise with clients, prepare reports, plans and procedures.
• Excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate several tasks simultaneously.
• Ability to work under pressure in a multi-disciplinary team environment.
• Intermediate to advanced MS Word and Excel.
• Prior experience working within a safety / pharmacovigilance database (desirable)
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