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Pharmacovigilance Services Specialist

5-10 years
Not Disclosed
10 Sept. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Pharmacovigilance Services Specialist
Location: Bengaluru, India
Job Type: Full-time
Experience: 5–11 years
Job ID: AIOC-S01602394
Category: Pharmacovigilance / Drug Safety


About Accenture

Accenture is a global professional services company with expertise in digital, cloud, and security, serving clients across more than 40 industries in over 120 countries. Our 699,000 people deliver innovative solutions every day, enabling life sciences companies to improve patient outcomes and bring their vision to life.


Job Overview

The Pharmacovigilance Services Specialist is responsible for managing case processing, safety data review, and regulatory reporting for clinical trials and marketed products. The role includes team leadership, ensuring compliance with global regulatory standards, and contributing to the strategic direction of pharmacovigilance operations.


Key Responsibilities

  • Manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database.

  • Manage the Affiliate Mailbox and perform reconciliation of reports as per client processes.

  • Conduct written follow-ups for both serious and non-serious cases.

  • Ensure all activities comply with global regulatory requirements and client-specific guidelines.

  • Support team operations, including providing guidance and oversight to small teams or individual contributors.

  • Solve moderately complex problems and adapt existing methods or procedures for new situations.

  • Interact with peers, supervisors, clients, and management as required.

  • Work rotational shifts if necessary.


Qualifications

Educational Requirements:

  • Any Graduation / Bachelor of Pharmacy (BPharm) / Master of Pharmacy (MPharm)

Experience Requirements:

  • 5–11 years in pharmacovigilance, safety surveillance, or drug safety operations

  • Experience managing small teams or work efforts

Language Requirements:

  • Japanese proficiency (JLPT N3–N5)

  • English fluency


Skills and Competencies

  • Teamwork and collaboration

  • Adaptability and flexibility

  • Quick learning and agility

  • Problem-solving and analytical skills

  • Ability to follow strategic direction from senior management

  • Knowledge of pharmacovigilance processes and regulatory requirements


Work Environment

  • Office-based in Bengaluru

  • May require rotational shifts


Additional Information

  • Accenture is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, gender, sexual orientation, disability, veteran status, or any other protected characteristic.

  • Applicants are never required to make payments during recruitment.


Job Category Recommendation:
Pharmacovigilance / Drug Safety / Regulatory Affairs / Safety Surveillance