Pharamacovigilance Data Entry Operator (Fresher)

Job Title

Pharmacovigilance (PV) Data Entry Operator Fresher

Job Summary

We are seeking a detail-oriented PV Data Entry Operator (Fresher) to support pharmacovigilance activities by accurately entering, processing, and maintaining Individual Case Safety Reports (ICSRs) in compliance with regulatory guidelines and company SOPs.

Key Responsibilities

• Enter adverse event (AE) and adverse drug reaction (ADR) data into PV safety databases

• Perform data coding using MedDRA and WHO-Drug (basic level)

• Ensure accuracy, completeness, and consistency of case data

• Perform quality checks and resolve data discrepancies

• Maintain case timelines as per regulatory requirements

• Support case follow-ups and data reconciliation

• Maintain confidentiality and data integrity

• Assist in audit and inspection readiness

• Follow SOPs, GVP, and regulatory guidelines

Eligibility / Qualifications

• Educational background in:

• BSc / MSc Life Sciences

• BPharm / MPharm / PharmD

• Biotechnology / Microbiology / Nursing

• Freshers or candidates with 01 year experience can apply

• Basic understanding of pharmacovigilance concepts

Required Skills

• Strong attention to detail

• Good typing and data entry accuracy

• Basic medical terminology knowledge

• Ability to follow SOPs and timelines

• MS Word, Excel, and database basics

• Good written communication skills