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Medicines Safety Specialist
1 week ago
**Job Summary**
We are seeking a highly skilled Medicines Safety Specialist to join our team at the Ministry of Health in Wellington. As a key member of our Product Safety team, you will play a pivotal role in monitoring potential quality issues, ensuring compliance with legislation, and managing corrective actions including recalls.
**Key Responsibilities:**
- Investigate Medicine Quality Issues: Review, risk assess, and act on reports of quality concerns and breaches of medicines legislation.
- Oversee Complaints & Recalls: Manage the complaints and recall process, ensuring adherence to internal SOPs and the New Zealand Recalls Code.
- Provide Technical Advice: Collaborate with teams to deliver accurate, risk-based decisions and advice on medicines.
- Regulatory Action & Compliance: Assist in regulatory action, including preparing materials for prosecutions and reviewing therapeutic advertisements for compliance.
**Requirements:
- A relevant tertiary qualification, preferably pharmacy or other sciences with an emphasis on medicines.
- Working knowledge of the regulation of medicines and management of post-market quality systems ideal, but is not essential.
- Experience, or interest in, working in a regulatory environment.
- Ability to develop working relationships within the health sector and industry.
- Strong written and oral communication and influencing skills, with the ability to communicate to different target groups including consumers.
