Drug Safety Specialist

About Avance Clinical

Avance Clinical is a Contract Research Organisation specialising in providing expert support for drug development to the pharmaceutical and biotechnology sectors. Recognized as leaders in this sector, the company has received numerous industry awards and successfully completed over 500 studies in the past five years. Since 2019, Avance Clinical has experienced consistent growth, doubling its size over the last two years and maintaining a positive outlook for the future.

Why Join Avance Clinical?

At Avance Clinical, employees are valued as the most important asset. The company fosters a friendly and enjoyable working environment grounded in principles of honesty and respect. Teamwork and collective achievement are prioritized while appreciating individual contributions.

Role Overview

The Drug Safety Specialist plays a critical role in managing drug safety data for specific projects. This includes preparing or reviewing Safety Reporting Plans (SRPs), collecting and processing safety events, and ensuring adherence to Clinical Study Protocols (CSP), company and sponsor Standard Operating Procedures (SOPs), ICH Good Clinical Practice (GCP) guidelines, and all applicable regulatory standards.

Key Responsibilities

• Receive, assess (initial and ongoing), process, and monitor safety-related events such as Serious Adverse Events (SAEs), Events of Interest (EIU), or Special Interest Events from clinical sites following CSP, regulations, SOPs, SRPs, and other agreements specifically related to clinical trial safety data management.
• Develop clear and accurate case narratives by collaborating with study Medical Monitors and Sponsor Medical Representatives, following study-specific SRPs and contractual obligations.
• Create, update, and review study-specific Safety Reporting Plans in alignment with CSPs and contractual requirements.
• Participate in study initiation meetings with project personnel as needed.
• Independently act as the Lead Safety Officer, overseeing regulatory compliance and the status of safety monitoring activities across assigned projects.
• Ensure prompt reporting, tracking, documentation, and distribution of safety information.

Qualifications and Experience

• Holder of a bachelor’s degree in a life sciences field.
• At least 2 years working experience in a safety or pharmacovigilance role or recognized pharmaceutical/CRO industry experience combined with relevant qualifications.
• A minimum of 4 years’ experience in the pharmaceutical or CRO industry operating under Good Clinical Practice (GCP) standards.
• Skilled in conducting literature reviews.
• Formal, current certification in ICH GCP guidelines.
• Experience preparing Development Safety Update Reports (DSUR) is beneficial.
• Strong knowledge of Australian regulatory frameworks and European Commission clinical trial safety reporting requirements.
• Proficient understanding of MedDRA and WHO Drug coding systems.
• Capability to communicate effectively with clients, senior management, and other stakeholders.
• Excellent written and verbal communication skills, including report, plan, and procedural document preparation.
• Exceptional organizational abilities enabling prioritization, problem analysis, solution development, and multitasking.
• Ability to perform under pressure within a multidisciplinary team environment.
• Intermediate to advanced proficiency with Microsoft Word and Excel.
• Previous experience using a safety or pharmacovigilance database is desirable.

Benefits

• Engaging and intellectually stimulating work.
• Diverse project involvement.
• An intellectually challenging environment.
• Flexible and agile workplace culture.
• Opportunities for professional career advancement.
• Job security and stability.
• A strong sense of workplace community.
• Leadership team focused on shared objectives.
• Flexible working arrangements.
• Access to quality tools and technology supporting job functions.
• Competitive salary package including an additional holiday on your birthday.

Additional Information

Applicants must be legally authorized to work in Australia. Avance Clinical is committed to diversity and inclusion, promoting cultural, disability, LGBTI+, and gender equality within the workplace. Candidates should submit their CV and cover letter combined in a single document for consideration.