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Data Officer – Pharmacovigilance & Safety Operations

Plg Groups
PLG groups
1-3 years
Not Disclosed
Remote, India, India
1 May 11, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Data Officer – Pharmacovigilance & Safety Operations (Remote, India)

Location: India
Work Mode: Remote
Department: Safety and Vigilance
Employment Type: Permanent

About the Role

We are hiring a Data Officer – Pharmacovigilance & Safety Operations for a leading life sciences and drug safety environment. This role is ideal for professionals with experience in vigilance data handling, pharmacovigilance case processing, regulatory reporting, and safety database management.

The selected candidate will be responsible for ensuring accurate, compliant, and timely processing of vigilance and safety data while supporting internal teams, regulatory authorities, clients, and global pharmacovigilance operations.

This opportunity is suitable for candidates with 1–3 years of experience in Pharmacovigilance, Drug Safety, or Case Management.


Key Responsibilities

Vigilance Data Management

  • Manage generic and client-specific pharmacovigilance email inboxes
  • Register initial vigilance and safety cases in internal tracking systems
  • Perform duplicate searches in client and internal safety databases
  • Conduct initial case triage and safety data entry
  • Perform MedDRA coding and prepare case narratives
  • Draft acknowledgements and follow-up communications
  • Handle case follow-up activities through phone and email interactions
  • Identify, document, and process vigilance-related cases
  • Maintain accurate tracking records and client documentation
  • Ensure data integrity, traceability, and compliance with pharmacovigilance standards

Regulatory Submission Responsibilities

  • Submit clinical and post-marketing safety cases to:
    • Competent Authorities
    • Ethics Committees
    • Partners and Affiliates
  • Notify clients as per SDEA and Technical Agreement requirements
  • Support administrative processing of pharmacovigilance and safety files
  • Ensure timely and compliant regulatory reporting activities

Database & Reporting Activities

  • Generate line listings and summary tabulations from safety databases
  • Execute database queries to support reporting requirements
  • Maintain accurate reporting documentation and case records
  • Support data extraction and reporting for internal and client needs

Eligibility Criteria

Educational Qualification

  • Bachelor’s or Master’s Degree in Pharmacy or related Life Sciences field

Required Experience

  • 1 to 3 years of experience in:
    • Pharmacovigilance
    • Drug Safety Operations
    • Case Processing
    • Vigilance Case Management

Technical Skills

  • Pharmacovigilance case triage and processing
  • Safety database handling
  • MedDRA coding
  • Regulatory reporting activities
  • Case tracking and reporting tools
  • Data management and documentation practices

Preferred Soft Skills

  • Strong English communication skills
  • Analytical thinking and attention to detail
  • Ability to organize and structure complex data
  • Client-focused mindset
  • Strong coordination and follow-up abilities