Covance

Quality Specialist, Pharmacovigilance

Job Location(s) IN-Pune
Job Number
2021-76620
Job Category
Drug Safety/Pharmacovigilance
Position Type
Full-Time
Telecommute
No

Job Overview

- Perform Quality review of assigned cases
- Assist in compiling quality metrics based on this review and identifying quality trends
- Assist in addressing periodic client quality reviews
- Assist in preparation of Corrective and preventive actions as requested
- Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers
- Assist in the conduct of process review for assigned process and measure and monitor audit readiness
- Assist in designing and tracking training schedule and training material for new hires and existing team.
- Contribute to discussion forums on Quality errors within assigned project and help identify process improvements
- Assist in coordinating respective client or external audits of the assigned projects as requested
- Assist in development of Quality Management Plan for assigned project
Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager

Education/Qualifications

- Bachelors/Masters degree in Medicine or Alternative medicine or Pharmaceutical science
- 2 plus years of overall work experience in the functional area with one year in Peer review/Quality review

Experience

- Bachelors/Masters degree in Medicine or Alternative medicine or Pharmaceutical science
- 2 plus years of overall work experience in the functional area with one year in Peer review/Quality review

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