- SalaryGreat salary package
- LocationSydney
- Job type Full Time
- DisciplineMedical Affairs
- ReferenceBH-41701
PV Associate - 12 month contract
Job description
About the company
This leading pharmaceutical company is renowned for its innovative approach to healthcare and robust pipeline. Combining passion with cutting-edge research and development, they have developed many widely used medicines across various therapeutic areas. Their contributions are instrumental in improving patient health and well-being globally.
About the opportunity
We are seeking a Pharmacovigilance Associate for a 12-month fixed-term contract. You will be responsible for a range of drug safety duties including case management, monthly reconciliations activities and developing RMPs.
Duties
Manage adverse event (AE) processing from various sources and ensure accurate and complete AE reporting.
Perform case entry, follow-up, and submission to regulatory authorities (TGA and Medsafe).
Conduct monthly reconciliation activities and six-monthly report submissions.
Develop and localize Risk Management Plans (RMPs) and collaborate on risk minimization activities.
Provide pharmacovigilance training to employees and partners.
Maintain safety agreements and ensure compliance with national PV regulations.
Contribute to the setup of compassionate supply and manage PV contracts with the team.
Skills and Experience
Bachelor's degree in a health profession (Pharmacy, Nursing) or life science field, or equivalent experience.
Minimum of 2 years of Australian pharmacovigilance experience.
Excellent communication, interpersonal, and organizational skills.
Strong quality management system knowledge.
Ability to manage multiple priorities independently.
Culture
The team is collaborative and value flexibility, open communication, and the ability to connect and work effectively. A team-oriented approach is crucial to succeed in this dynamic environment.
How to Apply
Click apply or contact Davina Ocansey-Gibson, Senior Recruitment Consultant, at +61 2 8877 8712 for a confidential discussion.