Pharmacovigilance Services Specialist
Job Details
Job Number: AIOC-S01664761
Location: Bengaluru, Karnataka, India
Job Category: Pharmacovigilance Operations / Drug Safety
Designation: Pharmacovigilance Services Specialist
Experience: 7–11 years
Qualification: Bachelor of Pharmacy / Master of Pharmacy
Employment Type: Full-time
Primary Skill: Pharmacovigilance & Drug Safety Surveillance
Role Overview
The Pharmacovigilance Services Specialist will be responsible for supporting pharmacovigilance operations and drug safety surveillance activities. The role involves end-to-end Individual Case Safety Report (ICSR) management, medical review support, affiliate mailbox reconciliation, follow-up activities, case processing, MedDRA coding, regulatory submissions, and compliance with client-specific procedures and global regulatory requirements.
The position requires the ability to manage moderately complex problems, develop or adapt existing solutions, work with cross-functional and client teams, and potentially manage small teams or work efforts.
Key Responsibilities
ICSR Case Management
Manage the identification and processing of Individual Case Safety Reports (ICSRs).
Perform case identification, data entry, case processing, and follow-up activities.
Process both serious and non-serious adverse event cases.
Ensure accurate and timely entry of case information into the safety database.
Perform MedDRA coding according to applicable procedures and client requirements.
Ensure cases are processed in accordance with client-specific guidelines and global regulatory requirements.
Perform case submissions within applicable regulatory timelines.
Maintain the quality, accuracy, and completeness of safety case information.
Affiliate Mailbox Management
Manage the affiliate mailbox and reconcile incoming safety reports according to established processes.
Identify potential safety reports received through affiliate channels.
Ensure appropriate case creation and processing following reconciliation.
Track and manage outstanding cases and required follow-up activities.
Perform written follow-up attempts for both serious and non-serious cases.
Ensure follow-up activities are documented appropriately within the safety database.
Pharmacovigilance Operations
Support day-to-day pharmacovigilance and drug safety surveillance activities.
Ensure compliance with established pharmacovigilance processes and procedures.
Review safety information for completeness and consistency.
Identify discrepancies or missing information and initiate appropriate follow-up.
Ensure pharmacovigilance activities are completed within defined quality and timeline requirements.
Support continuous improvement of pharmacovigilance processes.
Medical Review Support
Support activities associated with medical review of safety cases.
Review relevant clinical and safety information as required by the assigned process.
Support assessment and documentation of case information in accordance with client requirements.
Escalate medically or technically complex issues to the appropriate reviewer or supervisor.
Regulatory Compliance
Process and submit ICSRs in accordance with applicable global regulatory requirements.
Ensure adherence to client-specific pharmacovigilance procedures and quality standards.
Maintain compliance with applicable drug safety regulations and reporting timelines.
Ensure case documentation is complete, accurate, traceable, and audit-ready.
Support pharmacovigilance quality and compliance requirements.
Problem Solving and Process Improvement
Analyze and resolve moderately complex pharmacovigilance problems.
Develop new solutions by leveraging and adapting existing methods and procedures.
Identify opportunities to improve case processing, reconciliation, follow-up, and reporting activities.
Apply established methodologies while adapting approaches to address new assignments.
Escalate complex issues when required and support appropriate resolution.
Team and Stakeholder Management
Work closely with supervisors, peers, management, and client stakeholders.
Understand and align activities with the strategic direction and goals established by senior management.
Coordinate assigned activities to ensure team objectives are achieved.
Interact effectively with client teams and internal Accenture stakeholders.
Manage small teams or work efforts where required.
Provide appropriate support and guidance to team members when assigned supervisory responsibilities.
Ensure individual decisions and actions support overall team objectives.
Role Expectations
Work independently on assigned pharmacovigilance activities with appropriate guidance for new or complex assignments.
Apply sound judgment when determining methods and procedures for assigned activities.
Take ownership of assigned cases, processes, and deliverables.
Maintain accuracy and quality while managing multiple activities.
Meet established productivity, quality, and compliance requirements.
Communicate issues and risks to the appropriate level of management.
Adapt to changing client requirements and pharmacovigilance processes.
Work effectively in a process-driven and regulated environment.
Technical and Functional Skills
Pharmacovigilance Operations
Drug Safety Surveillance
Individual Case Safety Report (ICSR) processing
Case identification
Case data entry
Safety database management
MedDRA coding
Case follow-up
Serious and non-serious case processing
Regulatory case submission
Affiliate mailbox reconciliation
Written follow-up management
Pharmacovigilance compliance
Global regulatory requirements
Medical review support
Pharmacovigilance process improvement
Required Qualification
Bachelor of Pharmacy (B.Pharm) or
Master of Pharmacy (M.Pharm)
Required Experience
7–11 years of relevant professional experience.
Experience in Pharmacovigilance Operations and Drug Safety Surveillance.
Experience with ICSR case processing and safety reporting.
Experience with case identification, data entry, MedDRA coding, follow-up, and submissions.
Experience handling serious and non-serious safety cases.
Experience with affiliate mailbox reconciliation is highly relevant to the role.
Experience working according to client procedures and global regulatory requirements.
Work Environment
Full-time position.
Location: Bengaluru.
The role may require working in rotational shifts.
The position involves interaction with internal teams, client stakeholders, and management.
The role may include small-team or work-effort management responsibilities.
Core Competencies
Pharmacovigilance expertise
Drug safety surveillance
Analytical problem solving
Attention to detail
Regulatory compliance
Case management
Communication skills
Stakeholder management
Team coordination
Decision-making
Process improvement
Adaptability
Time management
Quality orientation
About Accenture
Accenture is a global professional services organization providing services across strategy and consulting, technology, operations, and digital transformation. The organization combines industry expertise, technology capabilities, and human ingenuity to support clients across multiple industries and countries.
Accenture emphasizes innovation, continuous learning, collaboration, inclusion, and professional development while providing opportunities to build and maintain relevant technical and functional skills.
Equal Employment Opportunity
Accenture is committed to equal employment opportunity. Employment decisions are made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status,
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