Pharmacovigilance Case Processing Associate

Why This Role Matters

Pharmacovigilance is the backbone of patient safety in the pharmaceutical industry. Every adverse event reported after a drug is marketed or during clinical development must be carefully evaluated, documented, and submitted to global regulatory authorities within strict timelines. Failure to do so can result in compliance risks, regulatory penalties, and potential harm to patients.
The Pharmacovigilance Services Associate role plays a vital function in ensuring that Individual Case Safety Reports (ICSRs) are accurately processed, coded, and submitted according to global regulatory requirements. By managing adverse event data, performing MedDRA coding, and ensuring submission compliance, this role directly contributes to drug safety surveillance and public health protection.
For pharmacy graduates with 1–3 years of experience, this position provides structured exposure to global pharmacovigilance operations within a leading professional services organization supporting major biopharmaceutical clients.

Job Description

Accenture is hiring for the position of Pharmacovigilance Services Associate under its Life Sciences R&D vertical. The role is part of the Clinical, Pharmacovigilance & Regulatory sub-offering, supporting global biopharma companies in maintaining drug safety and regulatory compliance.
The Pharmacovigilance Services Associate is responsible for case identification, data entry, MedDRA coding, case processing, regulatory submissions, and follow-ups for Individual Case Safety Reports (ICSRs). The position requires adherence to client guidelines, standard operating procedures (SOPs), and applicable global regulatory frameworks.
This role functions as an individual contributor within a team-based operational structure and may require rotational shifts depending on project requirements.

Key Features of the Role

• Exposure to global pharmacovigilance and drug safety surveillance
• End-to-end ICSR case processing responsibilities
• MedDRA coding and safety database management
• Regulatory submission compliance
• Structured operational workflow under Life Sciences R&D vertical
• Opportunity to work with global biopharma clients
• Team-based environment with defined scope of work

Responsibilities

The Pharmacovigilance Services Associate will perform the following core functions:
• Identify and triage adverse event cases from various data sources
• Perform accurate data entry into the safety database
• Conduct MedDRA coding for adverse events, indications, and medical history
• Process Individual Case Safety Reports (ICSRs) in accordance with global regulatory guidelines
• Perform quality checks and ensure completeness of safety reports
• Prepare cases for regulatory submission within defined timelines
• Conduct follow-ups for missing or incomplete information
• Maintain compliance with client-specific guidelines and SOPs
• Ensure documentation accuracy and audit readiness
• Escalate complex or unusual cases to supervisors when required
• Meet productivity and quality metrics defined by the organization
• Adapt to rotational shifts as per project requirements

Required Qualifications

Candidates must meet the eligibility criteria below.

Educational Requirements

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)
A pharmacy background is essential to understand medical terminology, drug safety concepts, and pharmacovigilance regulations.

Experience and Skills

• 1 to 3 years of experience in pharmacovigilance or drug safety operations
• Experience in ICSR case processing
• Knowledge of MedDRA coding
• Familiarity with global regulatory requirements (FDA, EMA, etc.)
• Understanding of pharmacovigilance workflows and safety databases
• Strong attention to detail and data accuracy
• Ability to solve routine problems using established guidelines
• Good written and verbal communication skills
• Ability to work independently within a team structure
• Willingness to work in rotational shifts

Candidates with prior exposure to Argus, ArisG, or other safety databases will have an added advantage.

Salary Insights

Compensation for this role is competitive and aligned with industry standards for pharmacovigilance professionals with 1–3 years of experience. Salary may vary based on expertise, project allocation, and prior case processing exposure.
In addition to base compensation, employees may receive performance-linked benefits and structured career progression within the Life Sciences vertical.

Company Overview

Accenture is a global professional services company with leading capabilities in digital, cloud, and security. With operations in more than 120 countries and a workforce of over 784,000 professionals, Accenture delivers Strategy and Consulting, Technology, and Operations services across industries.
Within the Life Sciences R&D vertical, Accenture supports pharmaceutical and biotechnology companies across clinical research, regulatory affairs, pharmacovigilance, and patient services. The organization combines scientific expertise with operational excellence to help biopharma companies bring safe and effective therapies to market.
Accenture emphasizes innovation, structured career growth, diversity, and global collaboration, offering professionals opportunities to build expertise in regulated healthcare environments.

FAQs

1. What is the primary responsibility of this role?
   End-to-end processing of Individual Case Safety Reports (ICSRs), including MedDRA coding and regulatory submissions.

2. Is prior pharmacovigilance experience required?
   Yes, 1–3 years of experience in pharmacovigilance or drug safety is required.

3. Does the role involve MedDRA coding?
   Yes, MedDRA coding of adverse events and medical terms is a core responsibility.

4. Are rotational shifts mandatory?
   Yes, this role may require working in rotational shifts based on project needs.

5. Is this a team-based or individual role?
   It is an individual contributor role within a structured team environment.

6. What vertical does this role belong to?
   It is part of the Life Sciences R&D vertical under Clinical, Pharmacovigilance & Regulatory services.

Application Tips

• Highlight your ICSR case processing experience clearly
• Mention safety databases you have worked on (e.g., Argus, ArisG)
• Showcase MedDRA coding experience with examples
• Include regulatory submission exposure
• Demonstrate accuracy metrics or quality scores achieved
• Mention flexibility for rotational shifts