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Pharmacovigilance Services Sr Analyst

5-8 years
Not Disclosed
10 Sept. 18, 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

Team/Level: Pharmacovigilance Services | Individual Contributor
Employment Type: Full-time
Experience Required: 2–5 years
Job Code: AIOC-S01602383
Location: Bengaluru, India


Company Overview:

Accenture is a global professional services company with expertise in digital, cloud, and security. With 699,000 employees across 120+ countries, Accenture delivers innovative solutions by combining technology and human ingenuity.

Learn more: www.accenture.com


Job Summary:

The Pharmacovigilance Services Senior Analyst will support Accenture’s life sciences clients by preparing, reviewing, and managing regulatory safety reports and individual case narratives. This role requires attention to detail, regulatory knowledge, and collaboration with peers and clients.

Key responsibilities include:

  • Preparing and reviewing:

    • RMP / PSUR / PBRER / DSUR / PADER / Addendum Statements

    • Addendum to Clinical Overview / US IND reports

    • Aggregate findings safety reports, Local reports, Cumulative reviews

    • Health Authority requests and assessment reports

  • Scheduling, authoring, peer reviewing, publishing, and tracking assigned reports.

  • Requesting inputs and performing literature screening for reports.

  • Managing the Affiliate Mailbox, reconciling reports per process, and performing written follow-ups for Serious and Non-serious cases.

  • Developing individual case narratives describing adverse events for regulatory submissions and safety reports.

  • Role may require rotational shifts.


Key Responsibilities:

  • Analyze and solve increasingly complex problems.

  • Interact mainly with peers within Accenture, with limited client/management interactions.

  • Perform daily tasks with minimal instruction; new assignments with moderate guidance.

  • Decisions impact own work and potentially the work of others.

  • May oversee small work efforts or teams (if required).


Qualifications:

  • Bachelor of Pharmacy (BPharm), Master of Pharmacy (MPharm), or BSc Nursing

  • 5–8 years of relevant pharmacovigilance experience

  • English proficiency (domestic) – Expert


Skills Required:

  • Pharmacovigilance Services – Safety Writing

  • Regulatory safety reporting and case narrative preparation

  • Knowledge of global regulatory requirements

  • Report scheduling, authoring, peer review, and tracking


Equal Opportunity Statement:

Accenture is committed to diversity and inclusion. Employment decisions are made without regard to age, race, religion, gender, disability, sexual orientation, or any legally protected status.


Additional Information:

  • Accenture provides learning, certifications, and diverse work experiences to keep skills relevant.

  • No fees are required for employment. Report fraudulent messages to: india.fc.check@accenture.com