Clinical Development Specialist

6 days ago

Pune, Maharashtra, India beBeeRegulatory Full time ₹ 15,000 - ₹ 28,00,000
Adverse Events and Product Quality Management:

As a key member of our team, you will be responsible for managing and reviewing expeditable adverse events, product quality complaints, and medical information. This involves submitting reports to clients and regulatory agencies within agreed timelines.

  • Manage adverse event and product quality complaint reports
  • Review medical information and ensure accuracy
Process Review and Audit Readiness:

You will assist in process reviews and measure/monitor audit readiness. This includes coordinating client or external audits of assigned projects.

  • Conduct process reviews and assess audit readiness
  • Coordinate client or external audits
Training and Development:

As part of our commitment to growth and development, you will design and track training schedules and materials for new hires and existing team members.

  • Develop training programs for new hires and existing team members
  • Track training schedules and materials
Quality Management:

You will contribute to quality error discussions and process improvements. Additionally, you will assist in developing Quality Management Plans for assigned projects.

  • Participate in quality error discussions and process improvements
  • Assist in developing Quality Management Plans
Data Analysis and Process Improvement:

Using data analysis techniques, you will suggest and drive process improvements. You will also track various types of information and metrics, conduct ongoing QC of defined process steps, and reconcile data from multiple sources.

  • Perform data analysis to identify areas for improvement
  • Drive process improvements using data analysis
Medical Information Queries:

You will respond to medical information queries, product quality complaints, and general queries received via telephone, email, fax, etc. You will also review recorded information and execute drug safety data management processes.

  • Respond to medical information queries and product quality complaints
  • Execute drug safety data management processes
Safety Data Management:

Guiding safety associates in managing voice calls as required is another aspect of this role. You will also review and drive strategies for process improvement/excellence.

  • Guide safety associates in managing voice calls
  • Review and drive strategies for process improvement
Regulatory Submissions:

Reviewing safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging Reports, Investigator Brochures, Clinical Study Reports, etc. is an important part of this job.

  • Review safety reports for global regulatory submissions
General Support Activities:

Additional support activities may be assigned to you on occasion.

Fortrea is looking for motivated problem-solvers who are passionate about overcoming barriers in clinical trials. We are committed to revolutionizing the development process to deliver life-changing ideas and therapies swiftly to patients in need.

Why Join Fortrea:
  • Collaborative workspace that nurtures personal growth
  • Global impact in clinical development
  • Innovative and excellent team environment

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