Drug Safety Scientist

NITZ Consulting Private limited

• 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.

• Experience

  5 - 10 Years

• No. of Openings

  2

• Education

  B.Pharma, MBBS, MD/Medicine Doctor, M.Pharma

• Role

  Drug Safety Scientist

• Industry Type

  Hospitals / Medical / Healthcare Equipments

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Home