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About Company

Indegene is a technology-led healthcare solutions provider driven by the purpose of enabling healthcare organizations to be future-ready. We offer accelerated global growth opportunities for talent that’s bold, industrious, and nimble. At Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy.

Position Name :

Drug Safety Associate

Organization :

Indegene

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

0 YEARS / Freshers - 1 Year

Salary:

25,000 - 35,000 /month

Location:

Bangalore

Responsibilities:

  • Confirm the validity of cases by identifying minimum criteria for case creation.
  • Perform duplicate searches to create either an initial case or a follow-up case.
  • Understand the principles and concepts associated with patient safety case-handling processes, including regulatory requirements for reporting individual case safety reports.
  • Identify serious adverse events and special scenario cases, including lack of efficacy, exposure, pregnancy cases, at-risk cases, and product quality complaint only cases.
  • Attach relevant source documents or any safety information/queries/follow-up information relevant to the case.
  • Facilitate follow-up based on queries from Data entry/QC/MR or based on inconsistent/missing information in the source file.
  • Code adverse events, medical history, lab data, indications, etc., using standardized terminology from a medical coding dictionary, such as MedDRA.
  • Code products (suspect/co-suspect, concomitant) as per client conventions and regulatory requirements.
  • Draft narratives.

Qualifications:

  • Understanding of principles and concepts associated with the case-handling process and overall drug research process.
  • Cognitive abilities, including verbal reasoning, attention to detail, and critical and analytical thinking.
  • Good knowledge of therapy areas and medical terminology.
  • Good comprehension skills.
  • Good communication skills (verbal and written) with fluency in English and interpersonal skills.
  • Immediate joiners only.

Application Link