Pharmacovigilance Specialist, Australia & New Zealand

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!

Pharmacovigilance specialist for Medison Australia & New Zealand, will be responsible for assisting the RA and PV Manager on the management of mainly PV activities and associated workflow and appropriate maintenance. To build and ensure appropriate organisational capabilities and deliverables.

Pharmacovigilance:

• Deputy of RA&PV manager in Australia & New Zealand
• responsible for the pharmacovigilance knowledge and expertise in the territory
• supports the local pharmacovigilance activity regarding Company’s products
• ensures compliance with the local and global PV requirements and as agreed with the partners in the territory
• Act as the subject area expert in PV for Australia & New Zealand
• Develop internal capabilities in the areas of PV to maintain full compliance both from a local regulatory perspective and in alignment with Global Medison requirements.
• Establishing and maintaining local pharmacovigilance system and procedures covering all activities required by regulations and safety agreements with partners.
• Create and revise local PV SOPs
• Collect and manage safety information obtained through various sources;
• Manage the submission of safety data to the local Regulatory Authority according to local regulations.
• Support the partners in local PV activities by providing information and governance of local PV activities
• Oversight/active involvement in localisation and implementation of RMP and additional Risk Minimization Measures in collaboration with other departments, partners, vendors.
• Create/conduct PV training programs to local Medison employees (including new employees) and vendors and ensure maintenance of awareness of drug safety reporting in general.
• Create and manage SDEAs/PVAs with partners and vendors. Ensure implementation of the relevant activities in the territory;
• Oversight and managing PV vendor
• Responsible to prepare and submit PSUR and RMP changes to Health authority as required and manage any reporting requirements
• Ensure PV inspection readiness at all times, including maintenance of APSS
• Subject matter expert for Medison pharmacovigilance system and responsible for currency
• Assist RA & PV Manager in local PV budgeting.
• Assist with additional tasks as assigned by RA & PV Manager.

General:

• Demonstrate effective communication, collaboration and leadership with all necessary stakeholders and partners to maximize ability to execute objectives in timely manner and with efficiency.
• Represent the organisation with internal & external stakeholders.

• A minimum of 3~7+ years of experience in PV activities
• Experience in managing RMP and PMS activities is preferred.
• Experience in reporting local ICSR cases to TGA and Medsafe is preferred.
• Experience in managing vendors, working with international companies is preferred
• Working knowledge of the TGA and Medsafe, international GxP regulations, guidelines, and emerging regulatory progresses.
• Knowledge of PV system design, development, implementation, and maintenance
• Experience with PV audits (internal and external)
• Not afraid to challenge the Status Quo and provide suggestions for improvement
• Highly collaborative team player that can successfully provide valuable feedback
• Ability to cope with ambiguity and lean structure
• Ability to work in highly dynamic and fast-growing organisation with demonstrated capability to be at ease in a matrix structure with ability to influence