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Pharmacovigilance Coordinator (Data Officer) 199

Product Life Group
Product Life Group
1-2 years
Not Disclosed
10 March 26, 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

Pharmacovigilance Coordinator (Data Officer) – PLG
Location: India (Remote Possible)
Category: Safety and Vigilance
Contract Type: Permanent

About ProductLife Group:
PLG is seeking a dedicated Pharmacovigilance Coordinator (Data Officer) to join our Hub and work closely with the PV team, ensuring compliance with regulatory standards and maintaining accurate safety data.

Key Responsibilities:

  • Vigilance Case Management:

    • Data entry of vigilance cases in relevant databases and AE forms.

    • Preparation of initial emails for follow-up requests and requests for clarification.

    • Quality control of vigilance cases.

    • Management of generic or client-specific email boxes, as appropriate.

    • Registration, triage, assignment, and coordination for processing of vigilance cases.

    • Processing vigilance cases received locally according to client specifications.

    • Client notifications and case submission to competent authorities (if required).

    • Conducting specific database queries for report drafting.

  • Pharmacovigilance Support:

    • Provide support to the business unit in other pharmacovigilance activities as needed.

Education and Experience:

  • Pharmacy Graduate or Bachelor’s degree with a scientific background.

  • 1-2 years of PV case management experience is a plus.

  • Prior experience in a similar position preferred.

  • Strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.

  • Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.

  • Experience in coordinating workload and activity management.

  • Experience communicating directly with clients.

  • Knowledge of safety databases (desirable).

Required Skills/Competencies:

  • Effective communication skills.

  • Reliable, organized, and punctual.

  • Previous experience in triage and processing of post-marketing cases.

  • Safety database experience.

Working Hours:

  • Central Europe Time coverage (1:30 PM – 9:30 PM IST).