Functional Quality Specialist I

3 weeks ago

Pune, Maharashtra, India Thepharmadaily Full time
Job Description

Adverse Events and Product Quality Management:

- Manage and review expeditable adverse events, product quality complaints, and medical information.
- Submit reports to clients and regulatory agencies within agreed timelines.

Process Review and Audit Readiness:

- Assist in process reviews and measure/monitor audit readiness.
- Coordinate client or external audits of assigned projects.

Training and Development:

- Design and track training schedules and materials for new hires and existing team members.

Quality Management:

- Contribute to quality error discussions and process improvements.
- Assist in developing Quality Management Plans for assigned projects.
- Support clients during regulatory inspections with the project team.

Data Analysis and Process Improvement:

- Perform and review data analysis to suggest and drive process improvements.
- Track various types of information and metrics, conduct ongoing QC of defined process steps, and reconcile data from multiple sources.

Medical Information Queries:

- Respond to medical information queries, product quality complaints, and general queries received via telephone, email, fax, etc
- Review recorded information and execute drug safety data management processes.

Safety Data Management:

- Guide safety associates in managing voice calls as required.
- Review and drive strategies for process improvement/excellence.

Regulatory Submissions:

- Review 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

General Support Activities:

- Perform additional support activities as assigned.

Who We Are Seeking:

Fortrea is looking for motivated problem-solvers and creative thinkers 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:

- Embrace a collaborative workspace that nurtures personal growth.
- Make a meaningful global impact in clinical development.
- Join an exceptional team dedicated to innovation and excellence

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