Instagram
youtube
Facebook

Pharmacovigilance Services Sr Analyst

2-8 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 Senior Analyst
Location: Bengaluru, India
Job Type: Full-time
Experience: 5–8 years
Job ID: AIOC-S01602383
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. We combine technology and human ingenuity to create value and shared success. Our 699,000 people deliver innovative solutions every day.


Job Overview

The Pharmacovigilance Services Senior Analyst is responsible for performing safety writing, medical review, and regulatory reporting for clinical trials and marketed products. The role involves authoring, reviewing, publishing, and tracking safety reports while ensuring compliance with global regulations and internal processes.


Key Responsibilities

  • Prepare and review regulatory safety reports including:

    • RMP, PSUR, PBRER, DSUR, PADER

    • Addendum Statements / Addendum to Clinical Overview

    • US IND reports, Aggregate Findings Safety Reports

    • Local reports and Cumulative Reviews

    • Health Authority requests and assessment reports

  • Schedule, author, peer-review, publish, and track assigned reports.

  • Request inputs and perform literature screening for assigned reports.

  • Manage Affiliate Mailbox and reconcile reports per internal processes.

  • Write and review individual case narratives describing adverse events for regulatory submissions and safety reporting.

  • Ensure all deliverables meet quality standards, compliance requirements, and timelines.

  • Work rotational shifts if required.


Qualifications

Educational Requirements:

  • Bachelor of Pharmacy (BPharm) / Master of Pharmacy (MPharm) / BSc Nursing

Experience Requirements:

  • 5–8 years in pharmacovigilance, safety writing, or related clinical operations

  • Experience in regulatory report preparation and safety data review


Skills and Competencies

  • Strong analytical and problem-solving skills

  • Ability to work independently and with minimal supervision

  • Good communication and interpersonal skills

  • Ability to handle complex regulatory documents and timelines

  • Knowledge of ICH-GCP and global pharmacovigilance regulations


Work Environment

  • Office-based in Bengaluru

  • May require rotational shifts


Additional Information

  • Accenture is an equal opportunity employer. All employment decisions are made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, or any other protected characteristic.

  • Employees are not required to make any payments during the recruitment process.