Medical Surveillance Specialist - Quintiles
Quintiles
2 - 6 yrs
Bengaluru/Bangalore , Mumbai
Job Description
- Monitors, evaluates and analyzes laboratory results on a daily basis, from sponsor central laboratory. Laboratory safety parameters are monitored for each patient at every site throughout clinical drug trial
Conducts preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using relevant clinical laboratory experience.
Maintains up-to-date laboratory knowledge via continuing education activities (i.e., completion of continuing education class, applicable QU courses, review of journal articles) or attendance at medical seminars
To participate in various Pharmacovigilance procedures including the processing of Adverse Event (AE) reports through tracking, data entry, quality control, report generation and submission, records management, as well as other project related and system support tasks
Based on clinical laboratory experience, identifies potentially significant trends or shifts in laboratory results and alerts Sponsor physicians
To perform CEVA (Clinical Event Validation and Adjudication) project tasks in the areas of endpoint adjudication committee coordination, core laboratory coordination, DSMB administration, and Steering Committee administration
Assist with Safety Reviews of Case Report Forms and Adverse Event and medical coding as requested
Company Profile:
Quintiles
Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions - from pipeline through portfolio to population health â„¢. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
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