Drug Safety Associate

Responsible for complete and accurate case processing of adverse event reports (ICSR) following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations.

This role would suit someone who has previous experience with writing PSUR and/or DSUR reports.

This permanent role will be based in Sydney or Melbourne, and we offer flexible and hybrid working arrangements.

Responsibilities:

• Configuring of applicable safety database with study-specific information
• Preparing study-specific safety management plan and related tools per client requirements, SOP and guidelines
• Clinical Trial / Post marketing ICSR Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness, triage of incoming cases to prioritise for daily workflow management, completion of narrative, manual coding, approval and reconciliation of safety data
• Liaison with medical monitors/Drug Safety physicians, clients and study teams as appropriate to clarify appropriate information required for case processing
• Prioritisation of data entry activities for cases by reference to the date of receipt in accordance with SOPs and guidelines
• Processing adverse event reports and maintaining safety database and tracking systems and preparing reports for regulatory authorities as required
• Strong presentation, documentation, interpersonal skills and high proficiency in English.
• Experience in drafting periodic reports (DSUR)

Minimum Qualifications & Experience:

• Registered nurse/pharmacist or with health/biomedical degree or other related scientific degree/qualification
• A minimum of 1 year safety-related experience in a pharmaceutical company/CRO environment
• Knowledge and experience in international Drug Safety-regulatory reporting obligations and compliance, coding applications, case processing, safety processes and tools is preferred.
• Good knowledge of medical terminology, ability to write clear, concise, unambiguous medical text is required.
• Ability to acquire knowledge in different disease and therapeutic areas, fluency in English, ability to evaluate data and draw conclusions independently, ability to follow guidelines and procedural documents (experience of working with SOPs) is preferred.
• Computer proficiency and ability to work in specific safety databases (e.g. Argus) is essential

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.