To assist the Head of Regulatory and the Vigilance team in activities and requirements within the company to achieve and maintain an effective complaint/vigilance system. Ensure regulatory compliance and transparency of complaints and adverse events within the organisation in line with the Company's policies, procedures, and applicable regulations. Some of the main tasks include:
- Logging, dealing with and investigating adverse event reports, incidents and complaints
- Preparation, review, and submission of Post Market Surveillance Data, including PMS Tracking, leading in PMS Board Meetings, PMS/PSUR Reports, PMCF Plans and PMCF Evaluation Reports, and trending.
- Assisting with the provision of the Vigilance training
- Support the review and update of Complaint and Vigilance Standard Operating Procedures.
The ideal candidate:
- 2-5 years' experience in dealing with adverse events or complaints, within the medical device, pharmaceutical or any other high regulated industry
- Background in Regulatory Affairs is beneficial
- Have great organisational, verbal and written communication, project management and time management skills.
- Ability to work under pressure to tight deadlines in a multidisciplinary environment.
- Highly customer focused and great attention to detail
your application has been submitted