Case Management - Specialist (Device Safety)

Case Management Specialist

Key Responsibilities

• Quality Assurance & Vendor Oversight:

  You will be accountable for the quality of device and combination product

  ICSR

  processing for both clinical trial and post-market cases. This includes ensuring vendors deliver high-quality cases through metric management and comply with worldwide regulatory authority requirements. You'll also be responsible for raising case-related issues and providing vendors with necessary training and resources.

• Regulatory Compliance & Reporting:

  Ensure compliance and timely reporting of device and combination product cases through the query process. This includes submitting all individual case safety reports to the

  FDA/EMA

  , business partners, and vendors. You'll also support audits and external inspections, including liaising with vendors as needed.

• Process Implementation & Support:

  Contribute to the implementation of new intake-related systems, processes, and procedures. You will apply analytical skills to evaluate moderately complex situations using multiple sources of information while applying multiple systems.

• Documentation & Standards:

  Work within the Quality Management System framework and implement Standard Operating Procedure requirements for device and combination product cases. You'll ensure the quality of

  PC

  ,

  AE

  , and

  OSF

  records.

Qualifications

• A Doctorate degree with 4 years, a Master's degree with 7 years, or a Bachelor's degree with 9 years of Drug Safety or Life Sciences experience.
• Experience in Pharmacovigilance or Quality within the biotech, pharmaceutical, or medical device industry is preferred.
• A Bachelor's degree in a health-care subject area or scientific field.
• An understanding of applicable global regulatory requirements, including

  Good Manufacturing Practices

  and

  Good Pharmacovigilance Practices

  .
• Previous experience with a corporate intake system or safety database.

Skills

• Analytical:

  The ability to apply analytical skills to evaluate moderately complex situations and develop solutions to technical problems.

• Attention to Detail:

  A high level of attention to detail to ensure high case-level productivity and quality.

• Communication:

  Strong communication skills to support interactions with business partners and vendors.

• Time Management:

  The ability to successfully manage your workload to meet strict timelines and consistently deliver on-time, high-quality results