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
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.
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.
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.
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
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
Office-based in Bengaluru
May require rotational shifts
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.
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