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Data Officer- (Local Safety)- India

PLG groups
2+ years
Not Disclosed
Remote, India, India
9 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

Data Officer – Local Safety (India)

Location

India (Remote work possible)

Work Schedule

Aligned with Eastern USA Time Zone

Employment Type

Permanent Contract

Department

Life Cycle – Safety and Vigilance

Company

ProductLife Group


Role Overview

The Data Officer – Local Safety is responsible for pharmacovigilance case intake, processing, quality control, and regulatory follow-up for client safety data in compliance with global drug safety regulations and timelines.


Key Responsibilities

1. Case Intake & Processing

  • Handle local safety case receipt and data entry

  • Perform case triage, assignment, and coordination

  • Manage generic and client-specific safety email inboxes

  • Ensure timely processing of Individual Case Safety Reports (ICSRs)


2. Follow-up & Communication

  • Conduct follow-ups with local reporters for missing or incomplete information

  • Respond to queries from clients and reporters

  • Support clarification of safety information during case processing


3. Quality Control & Tracking

  • Perform QC checks on safety cases and documentation

  • Track case progress and ensure compliance with timelines

  • Support reconciliation of safety reports for clients


4. Regulatory Compliance Support

  • Ensure compliance with GVP (Good Pharmacovigilance Practices)

  • Support adherence to FDA and EU pharmacovigilance regulations

  • Participate in audits and inspections

  • Assist in implementation of corrective action plans


5. Data Management & Safety Systems

  • Maintain safety databases and tracking systems

  • Ensure accurate documentation and traceability of case data

  • Support reporting and reconciliation activities


6. Cross-Functional Support

  • Support local pharmacovigilance activities as required

  • Collaborate with internal PV teams and clients

  • Contribute to operational efficiency of safety hub


Required Qualifications

Education

  • Bachelor’s or Master’s degree in:

    • Medicine

    • Pharmacy

    • Nursing

    • Life Sciences

    • Or related field


Experience

  • Minimum 2+ years in pharmacovigilance

  • Experience in service provider or CRO environment preferred

  • Experience in case processing, data entry, and QC


Technical Knowledge Required

  • Pharmacovigilance principles and adverse event reporting

  • Causality assessment methods

  • GVP, GCP, FDA, and EU PV regulations

  • Safety database systems experience

  • Understanding of regulatory reporting timelines and compliance


Key Skills

Operational Skills

  • Strong attention to detail and accuracy

  • Ability to work under strict deadlines

  • Process-oriented mindset

  • Strong time management and multitasking

Communication & Behavioral Skills

  • Strong written and verbal communication

  • Ability to explain complex PV concepts clearly

  • Team collaboration and coordination

  • Adaptability in dynamic workload environments

  • Accountability and ownership of tasks


Core Function

This role ensures accurate and compliant handling of pharmacovigilance safety data (ICSRs), supporting global drug safety monitoring and regulatory reporting obligations.