Pharmacovigilance Services Associate

Accenture is hiring a skilled and quality-driven Pharmacovigilance Services Associate to join our Life Sciences R&D vertical in Chennai. This role plays a critical part in helping global biopharma companies ensure medication safety by processing drug safety surveillance data and maintaining compliance with international health regulations.

Key Responsibilities & Scope of Work

• ICSR Management & Case Processing: Execute precise case identification, data entry, and comprehensive processing of Individual Case Safety Reports (ICSRs) within dedicated drug safety databases.
• Medical Coding & Standardisation: Apply accurate MedDRA coding to medical histories, adverse events, and patient indications in strict accordance with client guidelines and global coding principles.
• Regulatory Reporting & Compliance: Manage product safety data submissions and compile meticulous regulatory follow-ups to assist pharmaceutical clients in meeting strict safety surveillance compliance thresholds.
• Adverse Effect Analysis: Detect, assess, and document adverse reactions related to pharmaceutical products to identify potential risks and protect patient health.
• Team Operational Support: Work closely with team members and supervisors under general guidelines to resolve routine database issues and adapt effectively to scheduled rotational shifts.

Required Qualifications & Technical Stack

• Educational Background: Must hold a valid Bachelor of Pharmacy (B.Pharm), Bachelor in Physiotherapy (BPT), or BSc. Nursing degree.
• Domain Expertise: 1 to 3 years of hands-on experience in pharmacovigilance operations, patient services solutions, or drug safety data management.
• Core Competencies: High learning agility for new tools, excellent attention to clinical documentation details, strong collaborative team-working abilities, and adaptability to fast-changing environments.