PlusOne

Clinical Safety & Materiovigilance Specialist - MedTech - Wavre

Company

Our Client is a clinical stage, medical technology company headquartered in Wavre, Belgium. Based on its innovative, proprietary material, our Client has developed a pipeline of next-generation ophthalmic systems against Glaucoma. Glaucoma is the second leading cause of adult blindness globally. This technology represents the most promising and fastest-growing therapeutic option in the treatment of this disease.

Role

You are looking for an opportunity in order to have a large scope of responsibilities in the field of Safety (clinical and commercialized products)? You want to play a strategic but also operational role? You want to bring your expertise in MDD/MDR?

Plus One can offer a great challenge:

Your Responsibilities:

  • Safety Activities for Clinical Studies
  • Provide inputs to safety specific study-related documents (Protocol, Patient Informed Consent, CRF, Data Review Plan, Clinical Study Report)
  • Write Safety Management Plan and other safety documents in collaboration with Safety Monitor
  • Perform remote safety data review and cleaning according to the data review plan and follow up on resolution of safety queries
  • Work with clinical sites to obtain additional information related to specific safety issues
  • Write narratives for applicable adverse events and device deficiencies (in collaboration with Safety Monitor if required)
  • Support Safety Monitor in Safety Monitoring Committee management (schedule meeting, prepare safety reports for meeting, draft meeting minutes)
  • Manage safety operational activities in order to keep Safety Monitor activities focused on strategy
  • Provide a monthly safety report for the Clinical Team, highlighting specific issues from all clinical studies for action.
  • Support quality control & assurance activities related to safety (Internal QC, CRO & study site audit and safety CAPA resolution)

  • Safety Reporting of Clinical Studies
  • Review and assess adverse events and device deficiencies reported by study sites in collaboration with Safety Monitor
  • According to local laws, report adverse events to National Competent Authorities and Ethics Committee(s) globally, either directly or in collaboration with safety reporting partners
  • Keep up to date all safety related pre and post licencing SOPs according to the state of art
  • Report on Safety KPIs

  • Materiovigilance activities
  • Review post-market incidents to assess need for reporting
  • Submit serious incident reports to competent authorities and the notified body within the regulatory timeframe requirements and follow up as necessary until case closure
  • Interact with regulatory authorities during the execution of a field safety corrective action (FSCA) (write and submit FSCA report form, FSN). Collaborate with QA for timely FSCA execution and follow up until case closure
  • Write and submit trend reports and periodic safety reports to regulatory authorities
  • Analyze and identify statistical trends in incidents and FSCAs
  • Provide materiovigilance input for technical documentation (post-market surveillance plan, periodic safety update report, summary of safety and performance, risk management)

Profile

Education

  • Master degree in Life Sciences and / or a healthcare professional

Languages

  • Fluent in English, written and spoken. Knowledge of another language is beneficial

Professional Experience

  • At least 2 years of demonstrated experience in clinical safety and/or vigilance reporting of medical devices. Knowledge in MDR reporting requirements is essential.
  • Solid knowledge on medical terminology (ophthalmology experience is beneficial)
  • Basic knowledge of GCP (good clinical practices) and regulatory compliance guidelines for clinical trials
  • Knowledge/understanding of statistics

Personal Skills

  • Self-motivated, engaged and possess high quality leadership skills
  • Thorough and pay attention to detail
  • Can communicate effectively; set priorities and have time management skills
  • Able to use a computer and the main software packages competently
  • Team player with positive constructive attitude to solve problems
  • Eager to learn, stress resistant and ready to work independently in a start-up environment (hands on)

Offer

Our client offers an ambitious, dynamic and ever evolving start-up atmosphere and team. You would have the chance to get involved in the company evolution and in the full chain of development and ultimately help improve people’s life.

Our client offers a full-time open-ended contract with flexibility if your are living abroad.

Publication date

15.11.2021

Contact person

Gaëlle Minet

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