Project Lead, Patient Safety & Risk Management
Australia | Hybrid | Full-Time
Lead Excellence in Pharmacovigilance Delivery
Join our Patient Safety team as a Project Lead and take ownership of the operational delivery of patient safety and pharmacovigilance projects. In this role, you will lead project teams, manage client relationships, and ensure high‐quality, compliant delivery of safety services across assigned portfolios.
About the Role
In this role, you will:
General
* Support cross‐collaboration within the business by fostering relationships and collaborating with other business units to drive innovation, create efficiencies and expand service offering across the business.
* Provide high quality work that ensures client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision
Client Management
* Responsible for client set up and contract management.
* Act as the Primary point of contact and Subject Matter Expert (SME), for the project.
* Monitor project progress, track agreed KPI's and adjust plans as necessary to ensure project goals are met
* Escalate inconsistencies/out of scope requirements to the Senior Manager
* Prepare project reports to ensure project deliverables are met and activities performed by the project team are within the scope of the project
* Assist with preparations for internal and external audits
* Proactive contribution to improving business processes.
* Anticipate regulatory implications of emerging safety issues and offer clients strategies for handling/managing such issues.
Resource Management
* Supervision of project team to ensure the smooth delivery of the patient safety and pharmacovigilance service.
* Train and mentor other team members, also to be in line with company needs, client expectations and budget constraints.
Patient Safety & Risk Managemen
* Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria.
* Process & report safety data as per SOP's and client instructions in order to maintain client and regulatory compliance.
Act as part of PV & RS Team in line with the scope of the project in order to meet project outcomes and deliverables ensuring compliance.
* Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures.
* Maintain the integrity of client safety data registered into GxP databases and associated paper-based systems.
* Participate in the provision of after hour's safety related telephone services as required by the project scope.
What You Bring
* Degree in Pharmacy or a relevant scientific discipline (e.g. Pharmaceutical Sciences or Drug Development).
* Minimum 3 years' experience in patient safety or pharmacovigilance within a highly regulated environment (pharmaceuticals or medical devices).
* Minimum 2 years of experience in project management.
* Experience in adverse event case processing, literature surveillance, and project or client management.
* Strong knowledge of regulatory requirements for adverse event reporting in Australia and New Zealand, with broader awareness of EU, Japan, and APAC requirements.
* Excellent communication, organisational, and problem‐solving skills, with proven ability to work independently and lead teams.
Why Join Us?
* Work with a diverse range of clients across medicines, vaccines, and medical devices, expanding your technical expertise and making a meaningful impact in Patient Safety across multiple therapeutic areas
* Enjoy a flexible, hybrid work model and commitment to work-life balance
* Join a company that values expertise, excellence, collaboration and continuous improvement
Ready to make a bigger impact?
Click Apply Now and help shape the future of Patient Safety across JAPAC.
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