Pharmacovigilance ICSR Specialist

Cognizant; Taguig; On-site; PHP 360,000 - 540,000; Full time

Job summary

Cognizant is seeking a Pharmacovigilance Case Processing Associate to support the management of Individual Case Safety Reports (ICSRs) and ensure accurate safety data processing and regulatory compliance. This role is ideal for professionals with experience in Drug Safety, Pharmacovigilance, Case Processing, Argus Safety, Veeva Safety, MedDRA Coding, and Narrative Writing.

Key responsibilities include ICSR intake, data entry, case book-in, safety narratives, MedDRA coding, quality checks, and

Qualifications

• 1–2 years of experience in Pharmacovigilance, Drug Safety, or ICSR Processing.
• Hands-on experience with Argus Safety, Veeva Safety, Oracle Argus, Safety Database Systems or other PV platforms.
• Knowledge of Case Processing, Medical Coding / MedDRA Coding, Narrative Writing, Quality Review, Adverse Event Reporting.

Responsibilities

• ICSRs (Individual Case Safety Reports)
• Perform case intake, data entry, and case book-in activities
• Prepare and update safety case narratives
• Conduct MedDRA and product coding activities
• Perform quality checks and case reviews
• Manage workflow updates, case routing, and case closure
• Support labeling and regulatory compliance activities
• Ensure timely case reconciliation and submission readiness
• Maintain data accuracy within pharmacovigilance safety databases

Skills

Pharmacovigilance

Narrative Writing

Quality Review

Adverse Event Reporting

Education

Bachelor's degree in Pharmacy, Nursing, BS Medical Technology / Medical Laboratory Science, Biomedical Science, Molecular Biology or Pharmaceutical Chemistry

Tools

Argus Safety

Veeva Safety

Oracle Argus

Safety Database Systems

Job description

Cognizant is seeking a Pharmacovigilance Case Processing Associate to support the management of Individual Case Safety Reports (ICSRs) and ensure accurate safety data processing and regulatory compliance. This role is ideal for professionals with experience in Drug Safety, Pharmacovigilance, Case Processing, Argus Safety, Veeva Safety, MedDRA Coding, and Narrative Writing.

Key responsibilities include ICSR intake, data entry, case book-in, safety narratives, MedDRA coding, quality checks, and