PHARMAFull-time
Pharmacovigilance Manager
By Admin · Pharmacovigilance & Drug Safety
CHENNAI (IN)HYBRIDPOSTED: 8/25/2026
PHARMAFull-time
HIRING ORGANIZATIONICONContract Research Organization (CRO) / Clinical Research / Healthcare Services
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Lead the pharmacovigilance team responsible for collection, evaluation and reporting of adverse events while ensuring compliance with global regulatory requirements and internal standards.
Coordinate pharmacovigilance and drug-safety delivery, resolve operational issues and strengthen team capability.
Develop and implement pharmacovigilance processes and policies to improve the efficiency and effectiveness of safety-monitoring activities.
Collaborate with Clinical, Regulatory and Quality Assurance functions to support comprehensive safety assessments and timely safety reporting.
Provide training, coaching and guidance to team members and stakeholders on pharmacovigilance regulations, practices and procedures.
Monitor and analyse safety-data trends, prepare risk assessments and communicate findings to relevant stakeholders.
Ensure pharmacovigilance activities comply with global regulatory requirements, GVP/GCP expectations, SOPs, quality systems and internal quality standards.
People & Line Management
Directly manage a small-to-medium-sized pharmacovigilance team.
Manage workload allocation, coaching, mentoring and staff development.
Conduct performance reviews, establish objectives, provide performance feedback and manage employee development plans.
Support succession planning, recruitment and onboarding activities.
Build team capability and maintain appropriate resources and capacity to meet project deliverables, timelines and quality requirements.
Project, Resource & Operational Management
Support project delivery, resource planning, workload forecasting and risk management.
Communicate project status, risks, timelines and deliverables with clients, senior management and cross-functional stakeholders.
Generate and report operational metrics, perform data analysis, identify trends and support continuous process improvement.
Prepare management reports, dashboards, presentations and business updates using Microsoft Office and reporting/analytics tools.
Support audits, inspections and quality-improvement initiatives within the regulated environment.
Stakeholder & Communication Responsibilities
Interact effectively with clients, senior management, cross-functional teams and external stakeholders.
Deliver presentations and lead meetings across different organisational levels.
Conduct training sessions and influence stakeholders to maintain compliant, high-quality pharmacovigilance operations.
Work collaboratively across clinical, regulatory, quality and drug-safety functions.
Qualifications & Domain Expertise
Bachelor's degree or higher in Life Sciences, Pharmacy, Medicine, Nursing or another relevant healthcare/scientific discipline.
Strong pharmacovigilance experience with exposure to case processing, safety reporting, aggregate reporting, PV operations or related drug-safety activities.
Strong understanding of global pharmacovigilance regulations, GVP/GCP requirements, SOPs, quality systems and regulatory compliance expectations.
Demonstrated experience in resource and capacity planning, metrics, reporting, data analysis and trend identification.
Proficiency in Microsoft Excel, PowerPoint and Word and relevant reporting/analytics tools.
Excellent written and verbal communication skills.
Legal right to work in India is required.
Rewards & Benefits
Competitive base salary and performance-related incentives.
Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
Retirement and pension plans.
Life assurance and disability coverage.
Employee assistance programmes and wellbeing resources.
Learning and development opportunities through structured training and career pathways.
Benefits may vary according to role and location.
Inclusion & Accessibility
ICON states that it is an equal-opportunity employer committed to an inclusive and accessible workplace.
Reasonable accommodations are available during the recruitment process.
REQUIRED VERIFIED SKILLS
Pharmacovigilance
Drug Safety
Adverse Event Collection
Case Processing
Safety Reporting
Aggregate Reporting
PV Operations
GVP
GCP
SOPs
Quality Systems
Regulatory Compliance
Safety Data Analysis
Risk Assessment
Resource Planning
Capacity Planning
Metrics Reporting
Trend Analysis
Continuous Improvement
Microsoft Excel
Microsoft PowerPoint
Microsoft Word
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
ICON plc is a global provider of outsourced drug development and commercialization services to pharmaceutical, biotechnology, medical device, and government organizations. The company specializes in a broad range of clinical research services, from Phase I-IV studies to consulting and data solutions. ICON helps its clients accelerate the development of drugs and devices through comprehensive scientific and operational expertise.
TEAM SIZE: 41,100+ employees
INDUSTRY: Contract Research Organization (CRO) / Clinical Research / Healthcare Services
RECOMMENDED TRAINING
1/5
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