Patient Safety Associate - 14-month contract (Sydney, AU, Australia, NSW)

The Position

Are you passionate about patient safety and making a meaningful contribution to the safe use of medicines? This 14-month contract opportunity has been created to provide parental leave cover within the Patient Safety team. As a Patient Safety Associate, you will help ensure the effectiveness of Boehringer Ingelheim's Patient Safety operations across Australia and New Zealand, supporting activities that protect patients, meet regulatory obligations, and strengthen the local pharmacovigilance system.

You will be responsible for the management of Individual Case Safety Reports (ICSRs) and Safety Issue reporting, ensuring accurate assessment, documentation, and reporting in line with regulatory requirements and company procedures. Working collaboratively with local, regional, and global stakeholders, you will also contribute to patient safety initiatives, compliance activities, and the continuous improvement of pharmacovigilance processes and systems.

Tasks and Responsibilities

1. Pharmacovigilance Operations and Compliance

Execute and maintain high-quality ICSR management processes, ensuring the timely collection, assessment, documentation, and reporting of safety information to support patient safety and regulatory compliance.

Drive continuous improvement initiatives that enhance the effectiveness, quality, and compliance of local case management and pharmacovigilance activities.

Contribute to the management and reporting of Safety Issues by collaborating with cross-functional stakeholders to ensure appropriate assessment, escalation, and regulatory compliance.

2.  Quality Management and System Support

Support the continuous improvement of the local pharmacovigilance system through quality oversight activities, including reconciliations, literature monitoring, digital channel screening, compliance monitoring, and process enhancement initiatives.

Support audit and inspection readiness activities by maintaining compliant processes, documentation, and records, and contributing to the timely implementation of corrective and preventive actions where required.

3. Collaboration and Continuous Improvement

Collaborate with local and global stakeholders to support the implementation of Risk Management Plans (RMPs), risk minimisation activities, and other patient safety initiatives designed to protect patients and ensure regulatory compliance.

Prepare and maintain the Australian-specific annex to the Risk Management Plan (RMP), and contribute to the development and maintenance of local Product Information (PI) and Consumer Medicine Information (CMI) documents.

Contribute to a strong pharmacovigilance and patient safety culture by supporting compliance, inspection readiness, continuous improvement activities, and organisation-wide awareness of patient safety responsibilities.

About Our Future Employee

2 to 3 years of experience as a healthcare professional, such as a pharmacist, or as an appropriately qualified individual with pharmacovigilance experience with an understanding of the role patient safety activities play in protecting patients and supporting regulatory compliance.

Strong knowledge of pharmacology/pharmaceutics, safe use of medicines, with the ability to apply this knowledge to support regulatory reporting obligations.

Strong ability to collect, assess, and reconcile safety information from healthcare professionals, patients, and other sources, ensuring accurate and complete adverse event documentation in accordance with pharmacovigilance requirements.

Strong analytical and problem-solving skills, with the ability to prioritise competing activities, manage safety reporting timelines, and maintain compliance in a fast-paced environment.

Exceptional attention to detail, with a commitment to data quality, regulatory compliance, and maintaining inspection-ready patient safety records and processes.

Strong communication and stakeholder engagement skills, with the ability to work effectively across Medical, Regulatory Affairs, Quality, Commercial, and global Patient Safety functions to support a robust pharmacovigilance system.

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