Instagram
youtube
Facebook

Senior Drug Safety Associate

2-4 years
Not Disclosed
10 Dec. 23, 2024
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

Here’s the Pharmacovigilance - Data Entry and Safety Case Reporting job description:


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

1. Data Entry of Safety Reports

  • Responsible for data entry of individual case safety reports (ICSRs) into the safety database.

2. Review and Evaluation of Adverse Event Cases

  • Review and evaluate adverse event (AE) case information to determine the required actions following internal policies and procedures.

3. Timely Processing of Incoming Cases

  • Process all incoming cases in order to meet timelines and ensure prompt case handling.

4. Literature Search

  • Conduct literature searches as part of the pharmacovigilance process to identify relevant safety information.

5. Full Data Entry and Medical Coding

  • Perform full data entry, including medical coding and safety narratives.

6. Medical Coding Responsibilities

  • Responsible for coding all medical history, events, drugs, procedures, indications, and laboratory tests using the appropriate coding dictionaries (e.g., MedDRA, Company Product Dictionary, WHO-DD).

7. Writing Medically Relevant Safety Narratives

  • Responsible for writing medically relevant safety narratives for the cases, ensuring accuracy and completeness of the data entered.

8. Follow-up on Outstanding Queries

  • Follow up with sites regarding outstanding queries related to adverse event reports.

9. Reconciliation of Discrepancies

  • Assist in the reconciliation of discrepancies and ensure that all data is accurate and complete.

10. Adherence to AE Workflow Procedures

  • Follow departmental AE workflow procedures to ensure the consistency and compliance of the process.

11. Case Closure and Deletion

  • Responsible for the closure and deletion of cases, ensuring that all actions are completed appropriately.

12. Submission Activities

  • Perform submission activities when trained and assigned, ensuring all required documents are submitted to the regulatory authorities.

13. Good Documentation Practices

  • Understand and apply good documentation practices to ensure the integrity and accuracy of data.

14. Additional Drug Safety Activities

  • Perform any other drug safety-related activities as assigned by the team.

This position plays a critical role in maintaining the quality and accuracy of pharmacovigilance data, ensuring compliance with internal policies and regulatory requirements. Let me know if you need further modifications!