Senior Drug Safety Associate

Senior Drug Safety Associate

Overview

• Manage case processing across a diverse portfolio
• Top tier pharmceutical company
• Remote / on-site hybrid role

Benefits

• Work for a global leading sponsor
• Work on a close-knit team that encourages upskilling
• Get exposure to a diverse range of therapeutic areas
• Attractive salary package

About the company

Our client is a top tier pharmaceutical company that has a global presence and is growing at a fast pace. They have a diverse product portfolio that is improving the lives of millions of people worldwide.

About the opportunity

The senior drug safety associate team manages all pharmacovigilance activities and successfully manages the workflow by working cross functionally.

Duties

• Oversee the drug safety process including case collection, review, follow up and tracking
• Safety event reporting following applicable regulatory guidelines and company SOP’s, within timelines and applicable submission methods
• Conduct case follow up as appropriate
• Contribute to process improvements and managing periodic safety reports
• Work cross functionally and with local stakeholders to ensure compliance
• Review clinical trial literature and SOPs to identify trends and maintain up to date knowledge of local regulations
• Actively participate in team meetings and train and mentor staff on PVS and GCP

Minimum requirements

• Tertiary degree in life sciences or pharmacy
• 3 - 5 years local drug safety experience
• Ideally experience working in a sponsor or CRO
• In depth knowledge of ICH / GCP guidelines
• Highly organized with excellent communication skills
• Full Australian working rights

Culture

Join a high performing and innovative company that promotes an inclusive culture and rewards hard work.

How to Apply

Click apply or for a confidential discussion contact:

• Mattias Fitzgerald, Recruitment Consultant on +61 2 8877 8749