Drug Safety Senior Associate
Full-time opportunity that is initially a 12 month contract, with view to extending
Business and cross functional facing role with key responsibilities
Excellent team with a mature and dynamic way of working, whilst allowing autonomy and full support
About the company
Top Tier Pharmaceutical that prides itself on the teams and culture. Providing space for you to make your own decisions and reach out where necessary, all whilst being fully supported and sharing valuable knowledge.
About the opportunity
Support management of patient safety operational processes at country organisation in ensuring compliance with global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of the group marketed and investigational products
The role puts you in strategic position whereby you will be an integral part of the team
Leadership qualities are vital to the success in this position
Ensuring technical compliance of documents with technical guidelines
Involved with local and global procedures
Supporting teams cross functionally and external engagement, as this is a Business facing role
Manage collection, processing, documentation, reporting and follow-up of all adverse events reports for all group products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc.
Prepare and everyday distribute of respective Patient Safety (PS) documents internally and externally
Prepare the respective submission documents to Health Authorities, when applicable
Supervise proper flow of confirmations of receipt of documentation sent to the Health Authorities
Work with other local and global Patient Safety associates to ensure accurate evaluation of safety data
Focuses in the digital space/ social media
Skills and Experience
Recent experience or current experience working in a "Patient Safety Orientated Programme" or "Support Programme" essential.
Knowledge of pharmacological & medical terminology desirable
Experience on similar position in drug safety or drug registration or clinical research department would be an additional asset.
Proven ability to work in cross-functional teams
Excellent communication, interpersonal and negotiation skill
Collaborative, mature environment with honesty and integrity at the forefront. A science-based innovative organisation who thrive on discovering and developing breakthrough treatments.
How to Apply
Click apply or contact Amanda Hunt, Executive Consultant - Medical Affairs on +61 2 8877 8726 for a confidential discussion.
Drug Safety Senior Associate required for a Top Tier Pharmaceutical