Clinical Safety Manager
GenesisCare
full-time
Posted on:
Location Type: Remote
Location: Australia
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Tech Stack
About the role
- Lead and manage the Clinical Safety function, providing strategic, operational, and people leadership to ensure a high-performing, compliant, and inspection-ready safety department.
- Oversee end-to-end safety operations across clinical trials, including SAE and SUSAR management, medical review coordination, regulatory and ethics reporting, and ongoing safety oversight.
- Maintain oversight and ownership of the safety database, including study setup, data quality, system configuration, and ensuring the system remains compliant with regulatory and business requirements.
- Act as the primary point of accountability for safety governance, audit and inspection readiness, and safety-related Trial Master File (TMF) quality and compliance.
- Partner closely with Clinical Project Managers, Medical Monitors, and Sponsors to embed safety oversight into study delivery, risk management, and decision-making.
- Lead or act as Project Manager for safety-only projects and Sponsor engagements, ensuring delivery to scope, timelines, and regulatory expectations.
- Drive continuous improvement of safety processes, systems, and team capability within a lean CRO environment.
Requirements
- Tertiary qualifications in a science, life sciences or health discipline
- Minimum of 7 years’ experience in clinical research or regulatory roles, with at least 4 years’ experience in clinical safety or pharmacovigilance within a CRO, pharmaceutical, or biotechnology environment.
- Demonstrated experience with safety databases and safety system oversight.
- Experience with TARA PV is highly desirable.
- Strong knowledge of global pharmacovigilance regulations and guidelines, including ICH E2A, E2B, E2F, and ICH-GCP.
- Experience supporting oncology clinical trials is highly desirable.
- Experience with line management and team leadership is preferred.
- Experience contributing to regulatory inspections, audits, and Sponsor oversight activities.
- Strong written, analytical, and presentation skills.
- Ability to work independently with minimal supervision, demonstrating sound judgement, ownership, and accountability for decision-making.
Benefits
- Meaningful work that directly contributes to improved patient outcomes
- A collaborative, close-knit and purpose-driven team culture
- Flexible working arrangements to support work–life balance
- Internal and external training and professional development opportunities
- Award-winning learning and development programs
- Our Full Circle Wellbeing Program, supporting your physical, mental and financial wellbeing
- Free, confidential support services for you and your family (financial, legal, nutritional and wellbeing coaching)
- A range of employee benefits including Qantas membership discounts, access to My Fitness Passport, gym membership discounts and Bupa health insurance discounts and 12 weeks’ paid parental leave.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical safetypharmacovigilancesafety database managementSAE managementSUSAR managementregulatory reportingethics reportingsafety oversightTARA PVclinical trial management
Soft Skills
leadershipproject managementanalytical skillspresentation skillswritten communicationindependent workjudgementownershipaccountabilityteam leadership