Pharmacovigilance Services Analyst
Job Details
Job Number: AIOC-S01664799
Location: Chennai, Tamil Nadu, India
Job Category: Pharmacovigilance Services / Drug Safety
Designation: Pharmacovigilance Services Analyst
Experience: 3–5 years
Qualification: Bachelor of Pharmacy (B.Pharm)
Employment Type: Full-time
Primary Skill: Pharmacovigilance & Drug Safety Surveillance – P2
Role Overview
The Pharmacovigilance Services Analyst is responsible for supporting pharmacovigilance operations and drug safety surveillance activities. The role focuses on affiliate mailbox reconciliation, safety report management, Individual Case Safety Report (ICSR) processing, MedDRA coding, case data entry, regulatory submissions, and follow-up activities.
The position is designed for an individual contributor working within a focused scope of responsibility. The role involves solving lower-complexity problems, following established procedures, and working primarily with internal team members while providing updates to supervisors.
Key Responsibilities
Affiliate Mailbox Management
Manage affiliate mailbox reconciliation activities according to established processes.
Review incoming reports and identify potential safety cases.
Ensure appropriate reports are routed for case processing.
Perform written follow-up attempts for both serious and non-serious cases.
Track outstanding follow-up requirements.
Ensure follow-up information is appropriately documented.
Reconcile reports accurately and within established timelines.
ICSR Case Processing
Create and manage Individual Case Safety Reports (ICSRs).
Perform case identification and data entry.
Process safety cases in the applicable safety database.
Perform MedDRA coding according to established procedures.
Process both serious and non-serious cases.
Perform case follow-up activities.
Prepare and complete cases for regulatory submission.
Ensure case information is accurate, complete, and appropriately documented.
Process ICSRs in accordance with client guidelines and applicable global regulatory requirements.
Pharmacovigilance Operations
Support day-to-day pharmacovigilance and drug safety surveillance activities.
Follow established pharmacovigilance procedures and work instructions.
Ensure assigned safety cases are processed within required timelines.
Maintain appropriate quality and accuracy standards.
Identify discrepancies or missing information and escalate them appropriately.
Support ongoing pharmacovigilance operational activities within the assigned scope.
Regulatory Compliance
Process ICSRs according to applicable global regulatory requirements.
Follow client-specific pharmacovigilance procedures and guidelines.
Ensure safety cases meet required reporting timelines.
Maintain complete and accurate case documentation.
Follow established quality and compliance requirements.
Escalate potential compliance issues to supervisors when necessary.
Case Follow-Up
Perform written follow-up attempts for safety cases.
Follow up on missing or incomplete case information.
Document follow-up attempts in accordance with applicable procedures.
Monitor pending follow-up activities.
Ensure relevant information obtained through follow-up is incorporated into the safety case.
Problem Solving
Analyze and resolve lower-complexity pharmacovigilance problems.
Apply established methods and procedures to assigned activities.
Identify discrepancies and determine appropriate corrective actions within the defined scope.
Seek guidance from supervisors when issues fall outside established procedures.
Escalate complex or unusual cases appropriately.
Team Collaboration
Work as an individual contributor within a pharmacovigilance team.
Collaborate primarily with peers within Accenture.
Provide regular updates to supervisors.
Maintain effective communication with team members.
Support team objectives within the assigned scope of work.
Coordinate with relevant stakeholders when required.
Work Instructions and Supervision
Perform daily activities with moderate-level instruction.
Follow detailed instructions for new assignments.
Apply established procedures consistently.
Seek guidance when handling unfamiliar or complex activities.
Maintain accountability for assigned work and deliverables.
Technical and Functional Skills
Pharmacovigilance Operations
Drug Safety Surveillance
Individual Case Safety Report (ICSR) processing
Case identification
Case data entry
MedDRA coding
Safety database management
Case submission
Case follow-up
Serious case processing
Non-serious case processing
Affiliate mailbox reconciliation
Written follow-up management
Regulatory safety reporting
Pharmacovigilance compliance
Global regulatory requirements
Required Qualification
Bachelor of Pharmacy (B.Pharm)
Required Experience
3–5 years of relevant professional experience.
Experience in Pharmacovigilance Services or Drug Safety Surveillance.
Experience with ICSR case processing.
Experience with case identification and data entry.
Experience with MedDRA coding.
Experience with safety case follow-up.
Experience with serious and non-serious case processing.
Experience with affiliate mailbox reconciliation is relevant to the role.
Understanding of global regulatory requirements for pharmacovigilance activities.
Core Competencies
Pharmacovigilance knowledge
Drug safety surveillance
ICSR processing
MedDRA coding
Attention to detail
Data accuracy
Regulatory compliance
Case management
Problem solving
Time management
Process adherence
Team collaboration
Communication
Quality orientation
Ability to follow procedures
Escalation and issue identification
Decision-Making Scope
Decisions primarily impact the employee’s own work.
Decisions may also affect the work of other team members.
Work is performed within established procedures and defined processes.
Moderate guidance is provided for daily activities.
Detailed instructions are provided for new assignments.
Complex or unfamiliar issues are escalated to supervisors.
Client and Management Interaction
Primary day-to-day interaction is with peers within Accenture.
Supervisors are updated on work progress and issues.
Client and Accenture management exposure may be limited.
The role primarily focuses on execution of assigned pharmacovigilance activities.
Work Environment
Full-time position.
Location: Chennai, Tamil Nadu.
Individual contributor role.
Focused scope of work within a pharmacovigilance team.
The role may require rotational shifts.
Work is performed in a structured, process-driven, and regulated environment.
Career Level and Scope
This position is an early-to-mid-level pharmacovigilance operations role requiring approximately 3–5 years of experience. The primary focus is on accurate execution of established processes, including ICSR processing, MedDRA coding, affiliate mailbox reconciliation, follow-up activities, and regulatory safety reporting.
Compared with senior pharmacovigilance positions, this role has a more defined scope, lower decision-making authority, and greater reliance on established procedures and supervisor guidance.
About Accenture
Accenture is a global professional services organization providing capabilities across strategy and consulting, technology, operations, digital transformation, cloud, and security.
Accenture emphasizes innovation, collaboration, continuous learning, professional development, and an inclusive workplace. The organization provides opportunities for employees to develop relevant skills through certifications, learning programs, and diverse work experiences.
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, veteran status, sexual orientation,
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