Junior Vigilance & PMS Specialist

at  Skillspark AB

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.

• 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.