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Pharmacovigilance Services Specialist

Accenture
Accenture
7-11 years
Not Disclosed
Bengaluru, India
10 April 14, 2026
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance Services New Associate

Company: Accenture

Location: Bengaluru / Chennai, India

Experience Required: 0–1 years

Qualification:

  • B.Pharm / M.Pharm / MSc (Life Sciences)


Job Summary:

Entry-level role in drug safety (pharmacovigilance) focused on handling and processing Individual Case Safety Reports (ICSRs). You’ll ensure proper collection, evaluation, coding, and submission of adverse event data in compliance with global regulatory standards.


Key Responsibilities:

1. Case Processing (Core Work)

  • Create and manage ICSRs from multiple sources (emails, portals, databases)

  • Perform end-to-end case processing

  • Validate cases for completeness and medical relevance

2. Adverse Event Handling

  • Collect, evaluate, and document Adverse Events (AEs), SAEs, SUSARs

  • Assess seriousness and causality as per SOPs

3. Medical Coding

  • Code:

    • Adverse events → MedDRA

    • Drugs → WHO-Drug Dictionary

4. Data Management

  • Enter and manage data in global safety databases

  • Perform duplicate checks and data validation

  • Ensure data accuracy and completeness

5. Documentation & Narrative Writing

  • Prepare case narratives

  • Review source documents for validity

  • Request missing or unclear information

6. Regulatory Compliance

  • Follow SOPs, guidelines, and regulatory timelines

  • Ensure timely submission of safety reports

7. Additional Tasks

  • Handle follow-ups and queries

  • Participate in audits and inspections

  • Track cases and resolve pending actions


Skills Required:

  • Strong medical terminology knowledge

  • Basic understanding of:

    • Pharmacovigilance

    • Drug safety concepts

  • Good English communication (written + verbal)

  • Attention to detail

  • Ability to meet deadlines


Technical Skills:

  • MS Office

  • Safety databases (basic knowledge preferred)

  • MedDRA & WHO-Drug (preferred)


Work Environment:

  • Rotational shifts (important ⚠️)

  • Team-based work

  • SOP-driven structured workflow