Drug Safety Senior Associate

Drug Safety Senior Associate

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Benefits

• 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

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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.

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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

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Duties

• 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

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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

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Culture

Collaborative, mature environment with honesty and integrity at the forefront. A science-based innovative organisation who thrive on discovering and developing breakthrough treatments.

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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

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