Medical Device Case Reviewer

1 day ago

Hyderabad Secunderabad Telangana, India beBeeCase Full time ₹ 1,04,000 - ₹ 1,30,878

Job Title: Clinical Case Specialist

Job Description

You will be accountable for ensuring the quality of Individual Case Safety Reports (ICSRs) globally. This role involves significant vendor oversight, ensuring compliance with approved processes and maintaining a state of inspection readiness.

You will be a key point of contact for safety reporting and apply your analytical skills to evaluate moderately complex situations while ensuring timely and high-quality results.

  • Quality Assurance & Vendor Oversight: Ensure vendors deliver high-quality cases through metric management and comply with worldwide regulatory authority requirements.
  • Regulatory Compliance & Reporting: Ensure compliance and timely reporting of device and combination product cases through the query process.
  • Process Implementation & Support: Contribute to the implementation of new intake-related systems, processes, and procedures.
  • Documentation & Standards: Work within the Quality Management System framework and implement Standard Operating Procedure requirements for device and combination product cases.
Required Skills and Qualifications

Award-winning candidates possess:

  • 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.
Benefits

As a member of our team, you can expect:

  • Analytical skills to evaluate moderately complex situations and develop solutions to technical problems.
  • A high level of attention to detail to ensure high case-level productivity and quality.
  • Strong communication skills to support interactions with business partners and vendors.
  • The ability to successfully manage your workload to meet strict timelines and consistently deliver on-time, high-quality results.
Why Join Our Team?

We offer a dynamic work environment that encourages growth and development. As a valued member of our team, you will have opportunities to contribute to cutting-edge projects and collaborate with a talented group of professionals. You will be challenged to grow professionally and personally, and we are committed to supporting your success through training and development programs.

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