
Junior Vigilance Administrator
- Wrocław, dolnośląskie
- Stała
- Pełny etat
- Reporting to the EMEA Vigilance Manager – EMEA, the Vigilance Administrator will be responsible for supporting administrative activities associated with EMEA Vigilance Centre of Excellence ensuring compliance with internal and external requirements while fostering a culture of quality, innovation, and operational excellence.
- Monitoring and managing dedicated vigilance shared mailboxes for the team
- Collaborating with the Vigilance Specialists to submit Adverse Event reports to Regulatory Agencies and Notified Bodies, where applicable.
- Maintaining accurate records of vigilance-related activities within the TrackWise system, and the local tracker.
- Supporting the generation of metrics for Vigilance Leaders and Senior Management.
- Identifying and assessing vigilance-related risks and support the development of mitigation strategies.
- Supporting with non-reportable Decision Tree approval for SMAX related complaints
- Ensuring compliance with vigilance policies and procedures.
- Supporting and participating in audits performed by internal and external bodies.
- Assisting in identifying and implementing opportunities for process enhancements/optimization, including technology to enable PMQ organizational agility in relation to evolving business requirements, customer needs/experience and regulatory requirements.
- Undertaking any other duties as requested by EMEA Post Market Quality leadership to support the EMEA and Global Quality organisation.
- Strong attention to detail with strong organisational skills
- Good knowledge of Microsoft Office (Word, Excel, PowerPoint)
- Ability to lead multiple tasks and prioritize effectively with a pro-active attitude.
- Strong problem-solving skills, written and verbal communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Advanced command of English (C1 level)