Instagram
youtube
Facebook

Vigilance Specialist

2+ years
Not Disclosed
10 Nov. 5, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Vigilance Specialist

Function: Quality
Sub-function: Customer/Commercial Quality
Location: Diegem, Brussels-Capital Region, Belgium
Date Posted: October 30, 2024
Requisition Number: 2406220296W


About Johnson & Johnson:

At Johnson & Johnson, we believe that health is everything. With a rich history of healthcare innovation, we are committed to developing smarter, less invasive treatments to prevent, treat, and cure complex diseases. Through our combined expertise in Innovative Medicine and MedTech, we are uniquely positioned to deliver groundbreaking healthcare solutions that improve lives across the world. Learn more about us at www.jnj.com.

For over 130 years, Diversity, Equity, and Inclusion (DEI) have been integral to our culture and operations. Rooted in our Credo, we champion a culture where diverse perspectives are valued, and every individual can reach their full potential. We strive to create an environment where all voices are heard, and innovation thrives.


Job Overview:

We are currently looking for a Vigilance Specialist to join our team at Biosense Webster, Inc. in Diegem, Belgium. This position will play a key role in ensuring product safety, regulatory compliance, and customer satisfaction within a highly dynamic and fast-paced environment. As a Vigilance Specialist, you will be responsible for managing complaint investigations, ensuring compliance with regulations, and supporting a culture of continuous improvement.

This role is a great opportunity to be part of a global leader in medical device innovation, with the chance to contribute to the safety of patients suffering from cardiac arrhythmias and to ensure the highest standards of regulatory compliance.


Key Responsibilities:

  • Complaint Management:
    • Review and process product complaints, ensuring adherence to both internal procedures and external regulations.
  • Regulatory Reporting:
    • Determine regulatory reporting requirements and manage Health Authority Requests in compliance with EU MDR 2017/745 and other relevant global regulations.
  • Investigation Support:
    • Facilitate and oversee complaint investigations, working closely with relevant teams and creating follow-up questions to ensure thorough evaluations.
  • Audit and Compliance:
    • Support regulatory audits and compliance reviews. Maintain a deep understanding of quality system policies and regulatory guidelines.
  • Customer Satisfaction:
    • Enhance customer satisfaction by ensuring quick response times and effective resolution of issues.
  • Team Development:
    • Participate in onboarding and training of new team members to foster a knowledgeable and high-performing team.
  • Continuous Improvement:
    • Contribute to process improvement initiatives, working toward achieving operational excellence and meeting business goals.

Qualifications:

We would love to hear from you if you have the following qualifications:

  • A Bachelor's degree in Biomedical Science or a related field (preferred).
  • 2-3 years of experience in a regulated medical device or clinical environment.
  • Proficiency in English (both written and spoken).
  • Strong computer skills for data evaluation, regulatory reporting, and correspondence.
  • Experience in pharmacovigilance, medical device vigilance, or nursing (preferred).

What’s in it for YOU?

  • Competitive salary and benefits package, including a lunch card, wellness allowance, and employee discounts.
  • Flexible work options and work-from-home opportunities.
  • Professional development with training allowances and career growth opportunities.
  • Generous holiday days and share incentives.

Why Join Johnson & Johnson?

By joining Johnson & Johnson, you will have the opportunity to make a lasting impact on global healthcare. With our commitment to fostering a healthy workforce, you can grow both professionally and personally while contributing to a cause that touches millions of lives every day. At Johnson & Johnson, your talent can drive change and amplify your impact across the world.


Diversity, Equity & Inclusion:

At Johnson & Johnson, Diversity, Equity & Inclusion (DEI) means YOU belong. We strive to create an inclusive environment where diverse perspectives and experiences are valued. Our long-standing commitment to respecting the dignity and diversity of all is embedded in our Credo. Join us in creating a workforce that reflects the diverse markets we serve and builds a culture of belonging where everyone has the opportunity to reach their full potential.


Ready to Apply?
Join us at Biosense Webster and be part of our mission to innovate and improve the lives of those suffering from cardiac arrhythmias. Apply today to help make a difference in the healthcare industry and contribute to life-changing products.

 

4o mini