Benefits

Hold responsibility for the Medical Information function

Work in a collaborative and supportive environment

Innovative and global organisation

Flexible working arrangement

Work with a range of therapies and niche products

About the company

Our client is a medium sized speciality bio-pharmaceutical organisation developing and innovating products across a range of niche therapies. With an established and reputable senior management team the organisations boasts an outstanding culture that is collaborative and inclusive.

About the opportunity

Reporting to the Medical Director this role will hold responsibility for the Medical Information and Pharmacovigilance functions ensuring safety and compliance is adhered to with regards to Australian and New Zealand legislation. You will be the main point of contact for the TGA with regards to all relevant communications and enquiries.

Duties

• Hold responsibility and provide expertise for the Medical Information and Pharmacovigilance functions
• Product training from a safety perspective for the organisation
• Hold responsibility for risk management plans
• Product complaints and adverse event reporting
• Compliance in line with ANZ legislation
• Ensure CMIs and PIs are adherent with regulations for advertising and promotional activities
• Responsibility for supply of products through Special Access Schemes
• Build strong relationships with regulators and authorities both at a country and international level
• Align all medical information and PV activities to the organisations wider APAC community

Skills and Experience

• Minimum 5 years of experience in a similar role
• Expert knowledge in local pharmacovigilance legislation and requirements
• Consultative and influencing capability to drive others to achieve common goals and outcomes
• Ability make decisions without compromising quality
• Strong communication skills both internally and externally
• Multi task to manage consecutive projects whilst adhering to strict deadlines
• Analytical mindset in order to spot anomalies and forward plan

Culture

Small team environment with long-standing management.
Collaborative and inclusive
Autonomy and respect

How to Apply

Click apply or contact Angela Barclay, Associate Director on +61 2 8877 8743 for a confidential discussion.

( SK915184A )