Senior Manager, Patient Safety

About the Role

In this role, you will:

Lead and manage a team of pharmacovigilance professionals, ensuring clear roles, responsibilities, and effective performance in accordance with the Strategic Priorities, Purpose and Values.

Provide project leadership including client liaison, project scoping and proposal development, project team resourcing, project management and delivery and client follow up.

Act as Project Manager, lead assigned projects and support project teams as required.

Ensure compliance with local, global and regional PV regulations, including EMA, FDA, and ICH guidelines.

Ensure availability and effective management of pharmacovigilance obligations across multiple regions, ensuring timely compliance with local, global and regional PV regulations, including EMA, FDA, and ICH guidelines.

In conjunction with the Regional Head of Patient Safety, translate conceptual discussions into concrete project proposals, providing a realistic description of the scope of work and competitive cost estimate.

What You Bring

BPharm or relevant scientific qualification in disciplines such as drug development or pharmacology.

Minimum of 2 years’ solid experience in a Patient Safety Manager role in a pharmaceutical company or Medical Affairs environment OR 3 years’ solid PV experience in a consulting environment.

At least 2 years’ experience in a QPPV or Deputy role or equivalent.

Solid experience in pharmacovigilance and safety reporting in Australian and NZ from development phases throughout post-marketing surveillance.

Understanding and working experience of international PV guidelines particularly in Japan, SEA, US, EU and Canada.

Understanding of PV trends, legal and regulatory environment within pharmaceutical industry to facilitate industry best practice.

Proven experience with relevant Pharmacovigilance systems and databases, medicinal products, medical device and/or cosmetics.

Working experience with QMS including documentation management and implementing corrective and preventative actions in collaboration with QA.

Excellent written and oral communication skills.

Effective project management, process development and organizational skills. Ability to identify and understand issues, problems and opportunities using effective approaches for choosing a course of action or developing appropriate solutions.

Why Join Us?

Collaborate with some of the brightest minds in pharmacovigilance.

Contribute to projects that have real-world impact on patient care.

Enjoy a flexible, hybrid work model and commitment to work-life balance.

Join a company that values expertise, purpose, and progress.