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Pharmacovigilance Services Analyst

3-5 years
Not Disclosed
10 Nov. 7, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Pharmacovigilance Services Analyst

Skill Required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance
Location: [Insert Location]
Experience: 3-5 Years
Qualification: Any Graduation


About Accenture

Accenture is a leading global professional services company that combines digital, cloud, and security capabilities to deliver solutions across more than 40 industries. We provide Strategy and Consulting, Technology and Operations services, and Accenture Song, powered by the world's largest network of Advanced Technology and Intelligent Operations centers. With 699,000 employees serving clients in 120+ countries, we leverage technology and human ingenuity to help our clients achieve success. To learn more, visit www.accenture.com.


Job Overview

As a Pharmacovigilance Services Analyst, you will be aligned with our Life Sciences R&D vertical, providing support across the entire lifecycle of life sciences services—from clinical trials to pharmacovigilance. In this role, you will be responsible for the management and processing of Individual Case Safety Reports (ICSRs) in the safety database. This includes case identification, data entry, MedDRA coding, submission, and follow-ups, all in adherence to global regulatory requirements and client guidelines.


Roles and Responsibilities

  • Case Management: Create, manage, and process ICSRs, ensuring accurate data entry and MedDRA coding.
  • Data Submission & Follow-ups: Handle submissions and follow-up activities for both Serious and Non-serious cases in the safety database as per client instructions.
  • Analysis & Problem-Solving: Analyze and resolve lower-complexity issues related to case processing.
  • Team Collaboration: Regular interaction with peers within Accenture for guidance, and occasional exposure to clients and management.
  • Operational Efficiency: Perform all written follow-up tasks and reconciliation of reports according to the established process.
  • Shift Work: This role may require you to work in rotational shifts to support operational needs.

Skills and Qualifications

  • Any Graduation is required.
  • 3-5 years of experience in Pharmacovigilance, Drug Safety, or related roles.
  • Experience in ICSR case processing, data entry, and MedDRA coding.
  • Understanding of global regulatory requirements for drug safety.
  • Ability to analyze and address lower-complexity issues independently.
  • Strong communication skills for internal collaboration and occasional client interaction.
  • Comfortable working in rotational shifts.

What We Are Looking For

  • Attention to Detail: Precision in data management and case processing.
  • Adaptability: Ability to work effectively within a dynamic team environment.
  • Process-Oriented: Understanding and adherence to client guidelines and global regulations.
  • Problem-Solving: Ability to address challenges in case management with limited supervision.

Why Accenture?

  • Global Presence: Join a world leader in technology-driven solutions for life sciences.
  • Career Growth: Continuous learning and career development opportunities.
  • Innovation: Be part of a team that’s shaping the future of healthcare operations.