Pharmacovigilance Services New Associate | Drug Safety | Chennai
Company: Accenture
Location: Chennai
Job Type: Full-Time
Work Mode: On-site (Rotational Shifts)
Experience: 0–2 Years
Qualification: B.Pharm / BSc Nursing / Life Sciences
Job Overview
This is a high-demand entry-level role in pharmacovigilance and drug safety, focused on ICSR case processing, adverse event reporting, and regulatory compliance.
As a Pharmacovigilance Services Associate, you will handle end-to-end safety case processing, including adverse event (AE/SAE/SUSAR) evaluation, medical coding, narrative writing, and regulatory submissions. This role is critical in ensuring drug safety monitoring and compliance with global health authority regulations, making it a strong career path in drug safety, PV operations, and regulatory affairs.
Key Responsibilities
ICSR Case Processing & Drug Safety
Perform end-to-end ICSR (Individual Case Safety Report) processing
Prioritize, triage, and validate cases from multiple intake sources
Ensure compliance with regulatory timelines (TAT, SLAs, KPIs)
Adverse Event Management
Process and evaluate AE, SAE, and SUSAR cases
Assess seriousness, causality, and medical relevance
Perform follow-ups for missing or incomplete safety information
Medical Coding & Narrative Writing
Conduct medical coding using MedDRA and WHO-Drug dictionaries
Draft case narratives and E2B reports
Review source documents for accuracy and completeness
Regulatory Compliance & Submissions
Submit safety cases to global safety databases
Ensure adherence to GVP, ICH guidelines, and client SOPs
Handle data reconciliation, validation, and audit readiness
Quality & Process Management
Perform duplicate checks and case validation
Monitor and resolve queries, discrepancies, and follow-ups
Support audits, inspections, and pharmacovigilance documentation
Required Skills & Qualifications
Education & Experience
Bachelor’s Degree in Pharmacy, Nursing, or Life Sciences
0–1 year experience in pharmacovigilance / healthcare / clinical domain
Core Technical Skills
Strong knowledge of:
Pharmacovigilance (PV) Operations & Drug Safety
ICSR Case Processing
Adverse Event Reporting (AE/SAE/SUSAR)
Hands-on or theoretical knowledge of:
MedDRA Coding & WHO-Drug Dictionary
Global Safety Databases (Argus, ArisG, etc.)
ICH-GCP, GVP Guidelines & Regulatory Compliance
Medical & Writing Skills
Good understanding of medical terminology
Ability to draft clear and compliant case narratives
Strong attention to detail in data validation and coding
Technical & Soft Skills
Proficiency in MS Office and data handling tools
Strong English communication (reading, writing, speaking)
Ability to work under pressure and meet strict regulatory timelines
Quick learner with adaptability and analytical thinking
Perks & Benefits
Opportunity to work in global pharmacovigilance & drug safety projects
Strong career growth in PV, regulatory affairs, and clinical research
Exposure to international safety databases and compliance standards
Access to training, certifications, and skill development programs
Dynamic and performance-driven work environment
About the Company
Accenture is a global leader in healthcare, life sciences, and digital transformation services, supporting pharmaceutical companies in drug safety, regulatory compliance, and clinical operations. With a presence in over 120 countries, Accenture delivers innovation at scale.
Salary / Compensation
💰 Not disclosed in the job description (Competitive entry-level pharma package expected)
Work Mode
📍 On-site – Chennai, India (Rotational Shifts)
Call to Action
If you want to build a career in pharmacovigilance, drug safety, and regulatory compliance, this role gives you hands-on exposure to real-world safety case processing.
👉 Apply now and start your journey in the high-growth pharmacovigilance domain.
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