PHARMACOVIGILANCE SERVICES NEW ASSOCIATE
Company: Accenture
Location: Chennai, India
Job ID: AIOC-S01649704
Department: Life Sciences R&D – Pharmacovigilance Services
Employment Type: Full Time
JOB OVERVIEW
The Pharmacovigilance Services New Associate will support drug safety and pharmacovigilance activities by managing Individual Case Safety Reports (ICSRs), adverse event processing, MedDRA coding, case submissions, and follow-up activities. The role focuses on ensuring patient safety, maintaining regulatory compliance, and supporting pharmaceutical companies in monitoring the safety and efficacy of medicinal products.
KEY RESPONSIBILITIES
• ICSR Case Management
Create and manage Individual Case Safety Reports (ICSRs).
Perform case identification and intake activities.
Enter safety data accurately into pharmacovigilance databases.
Conduct MedDRA coding for adverse events and medical information.
Process safety cases according to client requirements and global regulations.
Manage follow-up activities to obtain missing information.
Support submission of safety reports to regulatory authorities.
• Pharmacovigilance & Drug Safety
Monitor and assess adverse event reports.
Support drug safety surveillance activities.
Ensure compliance with pharmacovigilance regulations and guidelines.
Maintain high standards of data quality and consistency.
Contribute to patient safety monitoring activities.
• Regulatory Compliance
Follow SOPs, work instructions, and client procedures.
Ensure regulatory timelines are met.
Maintain complete and accurate documentation.
Support audit readiness and quality compliance requirements.
• Team Collaboration
Work closely with team members and supervisors.
Participate in training and development programs.
Escalate issues appropriately when required.
Support continuous improvement initiatives.
• Daily Operations
Solve routine operational problems using standard procedures.
Execute assigned tasks with detailed guidance.
Work effectively within a team environment.
Adapt to changing priorities and project requirements.
Work in rotational shifts if required.
REQUIRED QUALIFICATIONS
Bachelor of Pharmacy (B.Pharm)
Bachelor's Degree in Life Sciences
Master's Degree in Life Sciences
EXPERIENCE
0–1 Year of Experience
Freshers are eligible to apply.
Internship or project exposure in Pharmacovigilance is preferred.
Basic understanding of drug safety and adverse event reporting is advantageous.
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