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Senior Drug Safety Associate

2-4 years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

📌 Senior Drug Safety Associate | Hyderabad
📍 Location: Hyderabad, India
🕒 Experience: 2-4 years in pharmacovigilance
💼 Department: Pharmacovigilance

Role Overview

The Senior Drug Safety Associate will be responsible for the data entry of individual case safety reports (ICSRs) into the safety database, evaluating adverse event (AE) case information, and ensuring compliance with internal policies and procedures. The role involves medical coding, writing safety narratives, and performing reconciliation and submission activities.

Key Responsibilities

Data Entry: Enter individual case safety reports into the safety database.
AE Case Evaluation: Review adverse event (AE) case information to determine required actions in line with internal policies.
Coding & Narratives: Perform medical coding and write safety narratives for AE cases, using dictionaries like MedDRA, WHO-DD, etc.
Follow-Up: Follow up with sites regarding outstanding queries and discrepancies.
Reconciliation & Submission: Participate in AE reconciliation and submission activities as required.
Documentation: Ensure adherence to good documentation practices and internal AE workflow procedures.
Other Tasks: Perform other drug safety-related activities as assigned by the department.

Qualifications

🎓 Education: Graduate/Post Graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or an equivalent degree.
💼 Experience:

  • 2-4 years of experience in Pharmacovigilance and drug safety.
  • Strong knowledge of MedDRA and WHO-DD coding systems.
  • Experience in reviewing and processing individual case safety reports (ICSRs).

Key Skills

  • Medical Coding: Expertise in coding medical history, events, and procedures.
  • Safety Narratives: Ability to write medically relevant and accurate safety narratives.
  • Attention to Detail: Strong focus on accuracy and completeness of data entry.
  • Communication: Clear communication for follow-ups and reconciliation.

Mode of Work

This position is on-premise.

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