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About the Role

Medison is a global pharmaceutical company focused on delivering groundbreaking therapies for rare and severe diseases. We are expanding our ANZ team and seeking passionate individuals to join us in making novel treatments accessible to patients worldwide.

Responsibilities

• Act as the Deputy of RA&PV manager in Australia & New Zealand.
• Serve as the pharmacovigilance expert for the territory.
• Support local pharmacovigilance activities for Company’s products.
• Ensure compliance with local and global PV requirements and partner agreements.
• Act as the subject matter expert in PV for Australia & New Zealand.
• Develop internal PV capabilities to ensure local regulatory compliance and alignment with Global Medison requirements.
• Establish and maintain the local pharmacovigilance system and procedures.
• Create and revise local PV SOPs.
• Collect and manage safety information from various sources.
• Manage the submission of safety data to the local Regulatory Authority.
• Support partners in local PV activities by providing information and governance.
• Oversee and actively participate in the localization and implementation of RMP and risk minimization measures.
• Create and conduct PV training programs for local employees and vendors.
• Create and manage SDEAs/PVAs with partners and vendors, ensuring implementation.
• Oversee and manage PV vendors.
• Prepare and submit PSUR and RMP changes to the Health Authority.
• Ensure PV inspection readiness at all times, including APSS maintenance.
• Serve as the subject matter expert for Medison's pharmacovigilance system.
• Assist the RA & PV Manager with local PV budgeting.
• Assist with additional tasks as assigned by the RA & PV Manager.
• Demonstrate effective communication, collaboration, and leadership with stakeholders.
• Represent the organization with internal and external stakeholders.

Requirements

• A minimum of 3-7+ years of experience in PV activities.
• Experience managing RMP and PMS activities is preferred.
• Experience reporting local ICSR cases to TGA and Medsafe is preferred.
• Experience managing vendors and working with international companies is preferred.
• Working knowledge of TGA and Medsafe regulations.
• Working knowledge of international GxP regulations, guidelines, and emerging regulatory progresses.
• Knowledge of PV system design, development, implementation, and maintenance.
• Experience with PV audits (internal and external).
• Willingness to challenge the status quo and suggest improvements.
• Highly collaborative team player capable of providing valuable feedback.
• Ability to cope with ambiguity and a lean structure.
• Ability to work in a highly dynamic and fast-growing organization.
• Demonstrated capability to thrive in a matrix structure and influence effectively.

Location

• Australia
• New Zealand

Work Type

• Full-time

Experience Level

• 3-7+ years

About the Company

• Medison stands as a distinctive global pharmaceutical company, driven by an unwavering purpose: to deliver groundbreaking therapies to patients suffering from rare and severe diseases across international markets.
• We believe that all patients, wherever they are in the world, have the right to get access to the best available novel treatments, and we are here to make this happen.
• As we continue our global expansion, we seek individuals who share our passion and principles, are eager to build and make a difference.
• We are patient-centric, innovative, agile, and always ahead.
• Come and join our growing ANZ team!