Drug Safety Scientist

NITZ Consulting Private limited

5 - 10 Years
2 Openings
15.0 - 20.0 Lac/Yr
Face-to-Face interview
Hyderabad

Key Skills

Pharmacovigilance Expert Clinical Researcher Clinical Trials Drug Safety Scientist Work From Home

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Job Description

• quality review of icsrs, surveillance of known or emerging safety issues, participation in an escalation process, risk evaluation, and analysis of safety data.

• apply safety concepts and regulations contained within fda cfr, ich, and eu gvp to management of safety data across the development life cycle.

• analyze aggregate safety data within a clinical program towards tracking and trending of risk assessments and additional mitigation measures.

• contributes to safety sections of the investigational new drug and new drug applications, investigator or regulator communications, investigator brochure, and other reports (dsur)

• participates in the set-up and maintenance of adverse event processes in global clinical trials

• ensure quality of the individual case safety report, including data and a concise, medically relevant narrative.