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Drug Safety Associate

Drug Safety Associate

QPS Bioserve

4 - 8 years

5 - 8 Lacs

Hyderabad

Posted:6 days ago| Platform:

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Skills Required

Serious Adverse Events-SAEs MedDRA PV Pharmacovigilance Safety Update Reports Clinical Research AE PSUR Drug Safety Case Processing

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Work from Office

Job Type

Full Time

Job Description

Role & responsibilities Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level. Perform case follow up activities such as identification of information to be collected during follow-up. Creating and reviewing case narratives. Providing client notifications as required for case management. Case downloading from regulatory authority websites Submission to applicable regulatory authorities within stipulated timelines Supporting and contributing to the development of training materials and training delivery. Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs. Acquire and maintain an up-to-date knowledge of global safety regulations for medicines. Peer reviews of cases for quality, consistency, and accuracy as needed. Other duties as assigned Preferred candidate profile Strong verbal, written and interpersonal communication skills. High level of accuracy and attention to detail. Excellent organization and prioritization skills; able to multitask. Basic knowledge of Pharmacovigilance. Interested applicants can also apply directly with updated CV to hr@qpsbioserve.com

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www.qps-bioserve.com

Biotechnology

Springfield

50-100 Employees

10 Jobs

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CTO
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Drug Safety Associate

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Skills Required

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