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Case Specialist (India)

PLG groups
4+ years
Not Disclosed
Remote, India, India
10 May 26, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Case Specialist (India) – Safety and Vigilance

Location

India (Remote work possible)

Employment Type

Permanent Contract


Role Overview

The Case Specialist is responsible for pharmacovigilance case processing, medical evaluation, and quality control of safety reports, ensuring compliance with global vigilance regulations and accurate case documentation.


Key Responsibilities

1. Pharmacovigilance Case Processing

  • Perform quality control of vigilance/safety cases

  • Enter case data into PV databases or client-approved systems

  • Perform follow-up of cases via phone or email

  • Close vigilance cases after complete evaluation


2. Medical Evaluation of Safety Reports

  • Assess causality between drug intake and adverse events

  • Evaluate seriousness and listed/unlisted nature of events

  • Conduct pre-analysis of complex cases before data entry

  • Perform medical review of vigilance files


3. Coding & Regulatory Compliance

  • Code adverse events using applicable medical dictionaries

  • Identify reporting requirements per case type

  • Apply regulatory standards (e.g., PV guidelines, authority requirements)

  • Support inclusion/exclusion analysis for regulatory reporting (ICSR/MHRA cases)


4. Quality Assurance & Documentation

  • Validate documents prepared by data teams

  • Prepare and review quality documents related to PV activities

  • Ensure accuracy and compliance in all case-related records


5. Medical Information Support

  • Handle medical information queries related to safety

  • Review customer complaints to identify potential safety signals

  • Answer calls generating safety notifications


6. Stakeholder Interaction

  • Act as key contact for assigned clients (with manager support)

  • Coordinate with internal teams for case resolution and reporting


7. Process Improvement

  • Identify requirements for PV system filters and improvements

  • Support updates to workflows and regulatory processes


Education & Experience

Education

  • Doctor of Pharmacy / Pharmacist qualification

Experience

  • 4–5 years of experience in pharmacovigilance or similar role


Key Skills Required

Technical Skills

  • Pharmacovigilance database experience (preferred)

  • Knowledge of drug safety regulations and reporting requirements

  • Medical coding (adverse event dictionaries)

  • Understanding of causality assessment methods

  • Proficiency in Microsoft Office tools


Behavioral Skills

  • Strong attention to detail and accuracy

  • Ability to work in a process-driven environment

  • Strong multitasking capability

  • Flexibility and adaptability

  • Good communication and teamwork skills

  • High level of rigor and compliance orientation


Core Function

This role ensures patient safety through accurate monitoring, evaluation, and reporting of adverse drug events in compliance with global pharmacovigilance standards.