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Pharmacovigilance Services Associate

Accenture
0-2 years
Not Disclosed
Bengaluru, India
15 Nov. 13, 2026
Job Description
Job Type: Full Time, Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

JOB DESCRIPTION: PHARMACOVIGILANCE SERVICES ASSOCIATE

COMPANY: Accenture
JOB TITLE: Pharmacovigilance Services Associate
JOB ID: AIOC-S01665479
JOB LOCATION: Bengaluru, Karnataka, India
JOB CATEGORY: Pharmacovigilance Operations
SKILL REQUIRED: Pharmacovigilance & Drug Safety Surveillance
SKILL LEVEL: P1
EMPLOYMENT TYPE: Full Time
EXPERIENCE REQUIRED: 1–3 Years
QUALIFICATION: Bachelor of Pharmacy (B.Pharm) / Master of Pharmacy (M.Pharm)


1. ABOUT THE COMPANY – ACCENTURE

Accenture is a global professional services organisation providing technology, consulting and business operations solutions across multiple industries.

The company supports pharmaceutical and healthcare organisations through technology-enabled services, operational management, business process optimisation and digital transformation.

Its major service areas include:

  • Healthcare and Life Sciences.

  • Technology and Operations.

  • Strategy and Consulting.

  • Digital Transformation.

  • Data Analytics.

  • Artificial Intelligence.

  • Business Process Management.

2. ABOUT THE ROLE

The Pharmacovigilance Services Associate position focuses on drug safety surveillance and pharmacovigilance case processing.

The selected candidate will work as a Drug Safety Associate, supporting pharmacovigilance operations for pharmaceutical clients.

The role primarily involves managing affiliate safety mailboxes, reconciling adverse event reports, processing Individual Case Safety Reports (ICSRs), performing MedDRA coding, entering safety information into pharmacovigilance databases and conducting follow-up activities.

The candidate must ensure accurate and timely processing of safety cases in accordance with client-specific procedures and applicable global regulatory requirements.

This is an individual contributor role involving routine pharmacovigilance activities under the guidance of a supervisor.

3. EDUCATIONAL QUALIFICATIONS

Mandatory qualifications:

  • B.Pharm – Bachelor of Pharmacy.

  • M.Pharm – Master of Pharmacy.

The job description specifically mentions Pharmacy qualifications.

4. EXPERIENCE REQUIREMENTS

Required experience: 1–3 years.

Relevant experience includes:

  • Pharmacovigilance Operations.

  • Drug Safety Surveillance.

  • ICSR Case Processing.

  • Adverse Event Reporting.

  • Safety Mailbox Management.

  • MedDRA Coding.

  • Case Data Entry.

  • Safety Case Follow-up.

  • Serious and Non-Serious Case Processing.

  • Affiliate Pharmacovigilance Operations.

5. KEY ROLES AND RESPONSIBILITIES

A. AFFILIATE MAILBOX MANAGEMENT

  • Monitor and manage the affiliate pharmacovigilance mailbox.

  • Receive adverse event reports from different sources.

  • Identify incoming safety information.

  • Review safety-related emails.

  • Identify potential adverse event cases.

  • Ensure appropriate documentation of received reports.

  • Route safety information according to established procedures.

  • Support timely processing of incoming safety reports.

  • Maintain accurate mailbox records.

B. ADVERSE EVENT REPORT MANAGEMENT

  • Receive and review adverse event reports.

  • Identify serious and non-serious adverse event cases.

  • Document relevant safety information.

  • Ensure accurate handling of safety reports.

  • Follow applicable client-specific procedures.

  • Support timely reporting of adverse events.

  • Maintain completeness and accuracy of safety information.

C. ICSR CASE IDENTIFICATION

  • Identify potential Individual Case Safety Reports (ICSRs).

  • Review incoming safety information.

  • Identify relevant patient and reporter details.

  • Verify available product information.

  • Identify adverse event information.

  • Check whether the report contains the minimum criteria for a valid ICSR.

  • Identify duplicate cases where applicable.

  • Ensure appropriate case identification according to client guidelines.

D. ICSR DATA ENTRY

  • Enter safety case information into the pharmacovigilance safety database.

  • Record patient information.

  • Enter reporter details.

  • Document suspected medicinal products.

  • Record adverse event information.

  • Enter relevant medical history, where available.

  • Document relevant laboratory and clinical information.

  • Ensure accurate and complete data entry.

  • Follow client-specific database requirements.

E. MedDRA CODING

  • Perform MedDRA coding of reported adverse events.

  • Identify appropriate medical terminology.

  • Select relevant Lowest Level Terms (LLTs).

  • Map reported terms to Preferred Terms (PTs).

  • Ensure accurate coding of medical conditions and adverse events.

  • Maintain consistency between source information and coded terms.

  • Follow applicable MedDRA coding conventions.

F. ICSR CASE PROCESSING

  • Process Individual Case Safety Reports.

  • Review available source documents.

  • Verify case information.

  • Enter relevant safety data.

  • Perform medical terminology coding.

  • Ensure case completeness.

  • Follow applicable case processing procedures.

  • Maintain case documentation.

  • Process cases within required timelines.

G. SAFETY CASE SUBMISSION

  • Support submission of processed ICSRs.

  • Ensure cases are prepared according to client requirements.

  • Follow applicable global regulatory reporting requirements.

  • Support timely submission activities.

  • Maintain submission-related documentation.

  • Track relevant case submission status.

  • Follow established quality and compliance procedures.

H. FOLLOW-UP ACTIVITIES

  • Perform written follow-up attempts for adverse event cases.

  • Manage follow-up activities for serious cases.

  • Manage follow-up activities for non-serious cases.

  • Identify missing information.

  • Request additional safety information where required.

  • Document follow-up attempts.

  • Track pending follow-up responses.

  • Update safety cases with newly received information.

  • Ensure follow-up activities are completed according to client timelines.

I. RECONCILIATION OF SAFETY REPORTS

  • Perform reconciliation of adverse event reports.

  • Reconcile reports received through affiliate channels.

  • Verify consistency between available records.

  • Identify missing safety reports.

  • Identify discrepancies in safety information.

  • Support resolution of reconciliation issues.

  • Maintain reconciliation documentation.

  • Follow established reconciliation procedures.

J. QUALITY AND REGULATORY COMPLIANCE

  • Follow client-specific pharmacovigilance guidelines.

  • Ensure accurate case processing.

  • Maintain appropriate safety documentation.

  • Follow applicable global regulatory requirements.

  • Adhere to Standard Operating Procedures (SOPs).

  • Meet case processing and submission timelines.

  • Identify errors and discrepancies.

  • Escalate issues to the appropriate supervisor.

  • Maintain confidentiality of patient information.

6. IMPORTANT PHARMACOVIGILANCE KNOWLEDGE

Candidates should have a good understanding of the following topics:

A. PHARMACOVIGILANCE FUNDAMENTALS

  • Definition and objectives of pharmacovigilance.

  • Adverse Drug Reaction (ADR).

  • Adverse Event (AE).

  • Serious Adverse Event (SAE).

  • Suspected Unexpected Serious Adverse Reaction (SUSAR).

  • Drug Safety Surveillance.

  • Post-Marketing Surveillance.

  • Clinical Trial Safety.

B. ICSR CASE PROCESSING

  • Case identification.

  • Minimum criteria for a valid ICSR.

  • Case intake.

  • Case data entry.

  • Case assessment.

  • MedDRA coding.

  • Narrative preparation.

  • Quality review.

  • Case submission.

  • Follow-up.

  • Case closure.

C. SERIOUS AND NON-SERIOUS CASES

Understand the difference between serious and non-serious adverse events.

Important seriousness criteria include:

  • Death.

  • Life-threatening condition.

  • Hospitalisation or prolongation of existing hospitalisation.

  • Persistent or significant disability.

  • Congenital anomaly or birth defect.

  • Other medically important conditions.

D. MEDDRA CODING

Important concepts include:

  • MedDRA hierarchy.

  • System Organ Class (SOC).

  • High Level Group Term (HLGT).

  • High Level Term (HLT).

  • Preferred Term (PT).

  • Lowest Level Term (LLT).

  • Medical terminology selection.

  • Coding conventions.

E. CASE FOLLOW-UP

  • Follow-up query preparation.

  • Missing information identification.

  • Serious case follow-up.

  • Non-serious case follow-up.

  • Follow-up documentation.

  • Case updates.

  • Follow-up tracking.

7. IMPORTANT REGULATORY GUIDELINES

Candidates should understand the basics of:

  • ICH E2A – Clinical Safety Data Management.

  • ICH E2B – Electronic Transmission of Individual Case Safety Reports.

  • ICH E2D – Post-Approval Safety Data Management.

  • ICH E2E – Pharmacovigilance Planning.

  • Good Pharmacovigilance Practices (GVP).

  • Good Clinical Practice (GCP).

  • Applicable global regulatory reporting requirements.

  • Client-specific pharmacovigilance SOPs.

8. PHARMACOVIGILANCE DATABASE KNOWLEDGE

Familiarity with safety databases is beneficial.

Examples of commonly used industry databases include:

  • Oracle Argus Safety.

  • ArisGlobal LifeSphere MultiVigilance.

  • Veeva Safety.

Important database activities include:

  • Case creation.

  • Case data entry.

  • MedDRA coding.

  • Case processing.

  • Case follow-up.

  • Case submission.

  • Case status tracking.

  • Database documentation.

The specific safety database used for this Accenture project is not mentioned in the job description.

9. REQUIRED TECHNICAL SKILLS

  • ICSR case processing.

  • MedDRA coding.

  • Adverse event identification.

  • Safety mailbox management.

  • Case reconciliation.

  • Follow-up management.

  • Safety database operations.

  • Regulatory compliance.

  • Documentation management.

  • Microsoft Office applications.

10. REQUIRED SOFT SKILLS

  • Attention to detail.

  • Good written communication.

  • Analytical thinking.

  • Problem-solving skills.

  • Time management.

  • Ability to meet deadlines.

  • Team collaboration.

  • Adaptability.

  • Willingness to learn.

  • Ability to follow instructions.

  • Accuracy in documentation.

  • Ability to work in rotational shifts.

11. ROLE AND REPORTING STRUCTURE

The position is designed as an individual contributor role.

The selected candidate will:

  • Work within the pharmacovigilance operations team.

  • Report to a direct supervisor.

  • Handle assigned safety processing activities.

  • Follow detailed operational instructions.

  • Resolve routine problems using established guidelines.

  • Escalate complex issues to senior team members.

  • Take responsibility for the accuracy of assigned work.

12. WORKING CONDITIONS

 

PARTICULARS

DETAILS

Company

Accenture

Job Title

Pharmacovigilance Services Associate

Job ID

AIOC-S01665479

Location

Bengaluru, Karnataka

Employment

Full Time

Experience

1–3 Years

Qualification

B.Pharm / M.Pharm

Primary Skill

Pharmacovigilance Operations

Secondary Skill

Drug Safety Surveillance

Skill Level

P1

Work Shifts

Rotational shifts may be required

13. IDEAL CANDIDATE PROFILE

The ideal candidate should possess:

  • B.Pharm or M.Pharm qualification.

  • 1–3 years of pharmacovigilance experience.

  • Basic to intermediate knowledge of ICSR processing.

  • Experience in adverse event case identification.

  • Knowledge of MedDRA coding.

  • Experience with safety database operations.

  • Understanding of serious and non-serious cases.

  • Experience in safety mailbox management.

  • Knowledge of case reconciliation.

  • Experience performing follow-up activities.

  • Understanding of global pharmacovigilance requirements.

  • Good documentation and communication skills.

14. IMPORTANT INTERVIEW PREPARATION TOPICS

Candidates preparing for this position should focus on:

  1. Introduction to Pharmacovigilance.

  2. Difference between AE and ADR.

  3. Serious and Non-Serious Adverse Events.

  4. Six criteria of seriousness.

  5. Minimum criteria for a valid ICSR.

  6. ICSR case processing workflow.

  7. MedDRA hierarchy and coding.

  8. Serious and non-serious case follow-up.

  9. Case reconciliation.

  10. Affiliate mailbox management.

  11. Duplicate case identification.

  12. Case submission timelines.

  13. ICH guidelines.

  14. GVP and GCP.

  15. Safety database knowledge.

  16. Case documentation and quality checks.

  17. Regulatory reporting requirements.

15. CAREER GROWTH OPPORTUNITIES

This role can provide exposure to global drug safety operations and help build practical pharmacovigilance experience.

Potential future career opportunities include:

  • Drug Safety Associate.

  • Pharmacovigilance Specialist.

  • Senior Drug Safety Associate.

  • ICSR Quality Reviewer.

  • Pharmacovigilance Quality Analyst.

  • Senior Pharmacovigilance Associate.

  • Pharmacovigilance Team Lead.

  • Drug Safety Operations Specialist.

16. OVERALL JOB OBJECTIVE

The primary objective of the Pharmacovigilance Services Associate position is to ensure accurate, complete and timely processing of Individual Case Safety Reports (ICSRs).

The selected candidate will support end-to-end safety case activities, including affiliate mailbox management, adverse event identification, case data entry, MedDRA coding, case reconciliation, regulatory submission and follow-up activities.

The ultimate goal is to maintain high-quality pharmacovigilance operations and support patient safety through accurate drug safety surveillance.