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Senior Drug Safety Associate

Advity Research
ADVITY Research
2-4 years
upto 7.5 LPA
5 Aug. 7, 2024
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Drug Safety Associate

Location: Hyderabad

Experience Required: 2 to 4 years

Employment Type: Full Time

Department: Pharmacovigilance

Qualification:

  • Graduate/Post Graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent degree.
  • Fluency in English.

Mode of Work: On premise

Job Description:

  • Data Entry: Responsible for data entry of individual case safety reports into the safety database.
  • AE Case Evaluation: Review and evaluate AE case information to determine required action based on and following internal policies and procedures.
  • Case Processing: Process all incoming cases in order to meet timelines.
  • Literature Search: Conduct literature searches as needed.
  • Full Data Entry: Perform full data entry including medical coding and safety narrative.
  • Medical Coding: Responsible for coding all medical history, events, drugs/procedures/indications, and laboratory tests according to the appropriate dictionary (e.g., MedDRA, Company Product Dictionary, WHO-DD).
  • Safety Narrative Writing: Write medically relevant safety narratives of cases and check the completeness and accuracy of the data entered in the various fields.
  • Query Follow-up: Follow up with sites regarding outstanding queries.
  • Reconciliation: Follow-up on reconciliation of discrepancies.
  • AE Workflow Procedures: Follow departmental AE workflow procedures.
  • Case Closure: Responsible for closure and deletion of cases.
  • Submission Activities: Perform submission activities when trained and assigned.
  • Good Documentation Practices: Understand and apply good documentation practices.
  • Additional Tasks: Perform any other drug safety related activities as assigned.