Pharmacovigilance Services Associate Manager
Location: Bengaluru, India
Employment Type: Full-time
Experience Required: 5–10 years
Job ID: AIOC-S01621667
Company Overview
Accenture is a global professional services leader, offering expertise in digital, cloud, security, and consulting across 40+ industries. With over 784,000 professionals in 120+ countries, Accenture helps organizations transform their operations, achieve business growth, and deliver innovative solutions.
Visit: www.accenture.com
Role Overview
The Pharmacovigilance Services Associate Manager will lead and oversee drug safety operations, including medical review, case assessment, and team management. This role ensures regulatory compliance, high-quality safety reporting, and effective training and guidance for team members. The ideal candidate will have strong medical expertise, pharmacovigilance experience, and leadership capabilities to manage large teams in a metrics-driven environment.
Key Responsibilities
Medical Review & Pharmacovigilance Operations
Conduct medical review of Individual Case Safety Reports (ICSRs), assessing seriousness, causality, labeling, and accuracy in compliance with client SOPs and global regulatory standards.
Provide company causality comments, verify MedDRA coding, and ensure proper documentation in the Global Safety Database.
Address medical assessment queries from case processing associates, literature reviewers, and quality reviewers.
Support audits, inspections, and compliance activities.
Team Leadership & Resource Management
Lead, mentor, and train internal and cross-functional teams on SOPs, regulatory updates, and pharmacovigilance best practices.
Allocate resources efficiently, monitor team performance, and implement corrective actions to achieve KPIs and SLAs.
Foster continuous improvement and adoption of best practices across processes and operations.
Recruit, evaluate, and develop high-performing team members.
Process & Client Management
Ensure adherence to client policies, SLAs, and KPIs while maintaining high-quality deliverables.
Coordinate and supervise workflow processes, propose updates to SOPs, and implement process enhancements.
Participate in client meetings, escalate issues appropriately, and act as a liaison between the client and internal teams.
Oversee literature QC, documentation archiving, and regulatory submission support as required.
Performance & Reporting
Monitor project progress, evaluate team performance metrics, and implement actionable improvements.
Approve literature requests, validate database updates, and ensure accurate tracking of all pharmacovigilance activities.
Drive projects to completion with high quality and within timelines.
Qualifications
Educational Requirements:
MBBS or MD (Medical Degree)
Experience Required:
5–10 years of experience in pharmacovigilance, drug safety, or clinical data management.
Prior experience managing large teams in PV or clinical functions is essential.
Skills & Competencies:
Strong understanding of medical terminology, MedDRA, and WHO-Drug dictionaries.
Proficiency in Microsoft Office and pharmacovigilance safety databases.
Excellent medical writing, communication, and analytical skills.
Ability to train, mentor, and guide teams effectively in a fast-paced, metrics-driven environment.
Attention to detail and ability to work independently while managing multiple priorities.
Why Join Accenture
Lead global pharmacovigilance operations impacting patient safety and regulatory compliance.
Opportunity to manage and mentor high-performing teams.
Gain exposure to multinational clients and global pharmacovigilance standards.
Work in an inclusive, collaborative, and innovative environment.
Access professional development, certifications, and career growth opportunities.
Equal Employment Opportunity
Accenture is committed to a diverse and inclusive workplace, making employment decisions without regard to age, race, gender, religion, disability, veteran status, or any other legally protected characteristic.
Important Notice: Accenture does not charge applicants for employment. Any request for payment is fraudulent. Report immediately to india.fc.check@accenture.com.
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