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Case Specialist (India)

Productlife Group
ProductLife Group
4-5 years
Not Disclosed
Remote
10 March 10, 2026
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm/Pharm.D 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: Case Specialist (India)
Company: Confidential / Not specified
Location: India (Remote work possible)
Employment Type: Permanent Contract
Functional Area: Life Cycle / Safety and Vigilance


Role Overview

The Case Specialist is responsible for quality control and medical evaluation of vigilance cases, ensuring compliance with regulatory standards, accurate data entry, and proper follow-up of adverse event reports. The role acts as a key contact for specific customers and supports the medical information division.


Key Responsibilities

Case Management & Evaluation:

  • Quality control of vigilance cases.

  • Medical evaluation of reports and files, including coding, causal relationships, seriousness, and listed/unlisted status.

  • Pre-analysis of complex cases before data entry.

  • Data entry into ad hoc databases or client-specific formats.

  • Closing vigilance files and ensuring submission requirements are met.

  • Support medical information inquiries and quality complaints to identify safety information.

Database & Document Management:

  • Validate documents produced by Data Managers, Vigilance Associates, or documentalists.

  • Set up or update ICSR/MLM filters.

  • Analyze inclusion/exclusion of EV/MHRA cases.

  • Write and maintain quality documents related to business unit activities or client-specific requirements.

Communication & Customer Support:

  • Follow up on vigilance cases via phone/email.

  • Act as key contact for specific clients under supervision.

  • Answer calls generating safety notifications.


Education & Experience

  • Doctor of Pharmacy / Pharmacist (required).

  • 4–5 years of relevant experience in vigilance, pharmacovigilance, or safety-related roles.


Skills & Competencies

  • Knowledge of current pharmacovigilance regulations.

  • Database management experience (preferred).

  • Strong process orientation and rigor.

  • Proficiency in Microsoft Office.

  • Excellent communication skills.

  • Ability to multitask, work in a team, and adapt to changing priorities.

  • Flexibility and organizational skills.