Pharmacovigilance Services Associate Manager
Job Details
Job Number: AIOC-S01664795
Location: Bengaluru, Karnataka, India
Job Category: Pharmacovigilance Operations / Drug Safety
Designation: Pharmacovigilance Services Associate Manager
Experience: 10–14 years
Qualification: MBBS / Master of Pharmacy / MD
Employment Type: Full-time
Primary Skill: Pharmacovigilance & Drug Safety Surveillance – P4
Role Overview
The Pharmacovigilance Services Associate Manager is responsible for managing pharmacovigilance operations and drug safety surveillance activities. The role involves oversight of Individual Case Safety Report (ICSR) management, affiliate mailbox reconciliation, case processing, MedDRA coding, follow-up activities, regulatory submissions, and compliance with client-specific procedures and global regulatory requirements.
The position requires strong technical and operational expertise, independent decision-making, problem-solving capabilities, and the ability to manage medium- to small-sized teams or work efforts.
Key Responsibilities
ICSR Case Management
Manage end-to-end Individual Case Safety Report (ICSR) processing activities.
Oversee case identification, data entry, MedDRA coding, case processing, submission, and follow-up activities.
Ensure processing of both serious and non-serious safety cases.
Ensure accurate, complete, and timely entry of safety information into the safety database.
Ensure cases are submitted within applicable regulatory timelines.
Monitor case quality, completeness, and compliance with established procedures.
Ensure ICSR processing follows client guidelines and applicable global regulatory requirements.
Affiliate Mailbox Management
Manage affiliate mailbox reconciliation activities according to established processes.
Ensure incoming safety reports are appropriately identified, assessed, and routed for case processing.
Oversee written follow-up attempts for serious and non-serious cases.
Monitor outstanding follow-up activities and ensure timely completion.
Ensure appropriate documentation of follow-up activities in the safety database.
Identify and resolve discrepancies arising during mailbox reconciliation.
Pharmacovigilance Operations
Manage day-to-day pharmacovigilance and drug safety surveillance activities.
Ensure operational processes are executed according to defined procedures and quality standards.
Monitor team performance against established quality, productivity, and compliance requirements.
Identify operational risks and implement appropriate corrective actions.
Ensure timely completion of assigned pharmacovigilance deliverables.
Support continuous improvement of pharmacovigilance processes.
Regulatory Compliance and Safety Reporting
Ensure safety cases are processed and submitted in accordance with applicable global regulatory requirements.
Maintain compliance with client-specific pharmacovigilance procedures.
Ensure adherence to reporting timelines and quality requirements.
Monitor regulatory and process requirements affecting case management activities.
Ensure appropriate documentation and traceability of safety information.
Support inspection and audit readiness for pharmacovigilance activities.
Problem Solving and Process Improvement
Analyze and resolve moderately complex pharmacovigilance operational problems.
Develop new solutions by leveraging and adapting existing methods and procedures.
Identify opportunities to improve efficiency, quality, and compliance.
Implement process improvements where appropriate.
Use analytical thinking to identify root causes and develop effective solutions.
Escalate significant risks and complex issues to appropriate management.
Team Management
Manage medium- to small-sized teams or work efforts at Accenture or client locations.
Provide direction and operational guidance to team members.
Allocate work and monitor progress against agreed timelines.
Review team performance and ensure delivery against quality and productivity targets.
Support team development and knowledge sharing.
Ensure team members understand and follow applicable pharmacovigilance procedures.
Address operational issues and provide appropriate guidance with minimal supervision.
Client and Stakeholder Management
Interact with client stakeholders and management levels within Accenture.
Maintain effective communication with peers, team leads, supervisors, and client representatives.
Understand client objectives and align pharmacovigilance operations accordingly.
Support resolution of client-related operational and process issues.
Communicate risks, challenges, performance issues, and improvement opportunities.
Build effective working relationships with internal and external stakeholders.
Operational Decision-Making
Work with minimal guidance when determining appropriate methods and procedures for new assignments.
Make decisions that may affect the immediate team and, occasionally, other teams.
Assess operational challenges and determine appropriate solutions.
Understand the strategic direction established by senior management and translate it into team objectives.
Take ownership of assigned work efforts and ensure successful delivery.
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
Safety case follow-up
Serious and non-serious case processing
Affiliate mailbox reconciliation
Written follow-up management
Pharmacovigilance compliance
Global regulatory requirements
Process management
Quality management
Operational risk management
Process improvement
Team management
Required Qualifications
MBBS
Master of Pharmacy (M.Pharm)
MD
Required Experience
10–14 years of relevant professional experience.
Strong 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 and follow-up processes.
Experience working according to client procedures and global regulatory requirements.
Experience managing or leading pharmacovigilance teams or work efforts.
Core Competencies
Pharmacovigilance expertise
Drug safety surveillance
ICSR management
Regulatory compliance
Case processing
MedDRA coding
Safety reporting
Analytical problem solving
Decision-making
Team leadership
Stakeholder management
Client management
Process improvement
Quality management
Operational risk management
Communication
Strategic thinking
Ability to work independently
Role Expectations
The Associate Manager is expected to operate with a high level of independence and provide effective operational leadership. The individual should be capable of solving moderately complex problems, developing new solutions, managing teams, coordinating client activities, and ensuring that pharmacovigilance deliverables meet established quality, compliance, and timeline requirements.
The role also requires the ability to translate strategic direction into operational team objectives and make decisions that may have an impact beyond the immediate team.
Work Environment
Full-time position.
Location: Bengaluru.
The role may require rotational shifts.
Regular interaction with client stakeholders and Accenture management.
Responsibility for medium- to small-sized teams or work efforts.
Work in a regulated, process-driven pharmacovigilance environment.
Career Level and Scope
This is a senior pharmacovigilance operations position requiring approximately 10–14 years of experience. Compared with an individual contributor Pharmacovigilance Services Specialist role, the Associate Manager position places greater emphasis on:
Team management
Operational ownership
Independent decision-making
Client interaction
Process improvement
Risk management
Strategic alignment
Performance management
Complex problem solving
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,
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