QA Medical Reviewer

Omega Healthcare

3 - 6 years

0 Lacs

bengaluru

Posted:16 hours ago| Platform:

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Skills Required

clinical research pharmacovigilance medical reviewer clinical

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

• Analysis, case intake and processing of adverse events from diverse therapy areas in to clients safety systems, ensuring 100% accuracy by conforming to the SOPs

Lay strong emphasis on quality, ensuring zero errors during all steps of ICSR processing
Proficient in end to end case processing. Activities include : Data verification , Data entry , coding of adverse events and drugs , causality assessments , case narratives and quality assessments
Exposure and proficient in working in ARISg and IRT / Argus/ any other safety databases
Lay strong emphasis on quality, ensuring zero errors during execution and/or review of comments while analyzing adverse events
Coordinate effectively with team members and stakeholders
Ability to train other team members on case processing concepts / practices

Preferred candidate profile

1-3 years of relevant work experience or clinical research organizations experience

Familiarity with workflows in PV safety databases/tools

Basic knowledge and understanding of the pharmaceutical regulations (FDA/EMA) and standards (ICH)
Computer proficiency (MS Office)
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Bachelor of Dental Surgery (BDS) / BSc in Nursing / B Pharm / M. Pharm or any other relevant degree from a reputed university

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