For one of our clients, we seek a resourceful and proactive Vigilance Specialist.
Key responsibilities
Assess incidents for reportability, using stakeholders from e.g. subsidiaries in countries around the world, Medical Affairs, Product Support, and manufacturing sites
Create manufacturers’ incident reports to authorities
Interact with authorities to answer requests
Deliver vigilance data for registration of products in new markets
Handle requests from authorities
Lead the task force for safety related issues, and handle field safety corrective actions, when needed
Own procedures and instructions related vigilance and PMS in our QMS
Effectively communicate vigilance regulatory requirements throughout the organization.
Follow worldwide regulatory development of the vigilance framework
Interact with stakeholders throughout the organization and provide vigilance training for relevant departments and subsidiaries
You have the below experience:
have a degree in pharmacy, life science, public health, or nursing
have vigilance or regulatory experience from the medical device or pharma industry
are structured, disciplined and know how to drive a vigilance process forward
can keep the overview and be decisive even with several cases on-going at once
have knowledge of regulations, standards and guidelines within the medical device area e.g. MDR, ISO 13485, and FDA 21 CFR 820.30
have strong communication skills and are fluent in English both verbally and in writing
As a person, you are a true team player with a positive and flexible mindset, who understands how to reach joint goals. You have a proactive mind-set and a constructive attitude to drive results combined with the ability to plan, execute and meet deadlines. You enjoy working with multiple tasks at the same time, are analytical and capable of digesting complex data without losing the overall picture.
Duration: End of the year + option
Allocation: 15 hours per week
