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Drug Safety Associate

2 weeks ago

Sydney, Australia Pettit Pharma & Device Search Full time

Pharmacovigilance Associate role in Sydney CBD
- Hybrid work environment
- 2+ years' experience required only

THE COMPANY YOU WOULD BE JOINING
- This company is a global, US headquartered, pharmaceutical company, that specialises in generic medicines, OTC and prescription medicines, within a globally driven market.
- They are currently looking for a Sydney based, Drug Safety Associate to start asap.

**BENEFITS**:

- If you’re someone who is motivated by the idea of working for a cause, this may be the place for you. This company is unconventional and are constantly challenging the status quo.
- Go to work knowing you help make a difference in the lives of the patients around the world by providing access to high quality medicines.
- Are you passionate about improving access to medicines and serving unmet needs to help patients globally?
- Are you passionate about your growth and learning and working in a collaborative team, with a great boss?

WHAT YOU WILL GROW AND BUILD
- The primary objective of this Drug Safety Associate position is the organisation, collection and submission of pharmacovigilance information for medicines (primarily - adverse events and adverse reactions) to Global Product Safety and Risk Management and the relevant authority in Australia and New Zealand in compliance with policy and local regulatory requirements.
- The role will support management with all pharmacovigilance activities including collection, review, follow up, tracking and reporting of adverse events in accordance with local regulations and local SOP’s.
- You will ensure reporting of local and international cases as applicable to the regulatory authorities and prepare reports for spontaneous adverse events of marketed products and clinically serious adverse events.
- You will track compliance for adverse event reporting timeframe and assist management with identifying any trends and issues arising from reports from the local safety database and from periodic safety reviews and alert management to any issues.
- You will liaise with local affiliate departments to ensure compliance and review individual reports, local literature and clinical trials, as required by local regulations for trends and issues arising from reports received.
- You will maintain up-to-date knowledge of pharmacovigilance requirements in Australia and New Zealand and any other relevant authorities.
- You will communicate and endorse safety practices, monitor key drug safety performance indicators and visibly participate in promoting drug safety policies and initiatives.

WHAT EXPERIENCE WILL YOU NEED TO GET THE JOB?
- University qualification in science or pharmacy.
- Minimum 2 years’ experience in the pharmaceutical industry in Australia, working in a drug safety/pharmacovigilance position.
- Ability to work in fast-paced, busy, corporate environment.