Pharmacovigilance Manager
Company: ICON
Job Requisition ID: JR158715
Employment Type: Full-time
Work Mode: Office With Flex
Location: Chennai, India
Posted: 16 days ago
About ICON
ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines and treatments to patients faster.
The organisation is driven by the values of Accountability & Delivery, Collaboration, Partnership, and Integrity.
Role Overview
As a Pharmacovigilance Manager, you will oversee pharmacovigilance and drug safety activities, ensuring the safety and efficacy of clinical trial products throughout their lifecycle.
The role focuses on PV delivery, team leadership, issue resolution, resource management, regulatory compliance, and team capability development.
Key Responsibilities
Lead the pharmacovigilance team in the collection, evaluation, and reporting of adverse events.
Ensure compliance with applicable regulatory guidelines and internal quality standards.
Develop and implement pharmacovigilance processes and policies.
Collaborate with Clinical, Regulatory Affairs, Quality Assurance, and other cross-functional teams.
Provide training and guidance on PV regulations, practices, and procedures.
Monitor and analyse safety data trends.
Prepare risk assessments and present safety findings to relevant stakeholders.
Ensure PV activities comply with global regulatory requirements, GVP/GCP requirements, SOPs, and quality systems.
Manage team workload, resources, capacity, and project deliverables.
Support continuous process improvement and quality initiatives.
Required Qualifications
Bachelor's degree or higher in:
Life Sciences
Pharmacy
Medicine
Nursing
Related healthcare/scientific discipline
Pharmacovigilance Experience
Strong PV experience with exposure to areas such as:
Case processing
Safety reporting
Aggregate reporting
PV operations
Drug safety activities
Global pharmacovigilance regulations
GVP/GCP requirements
SOPs and quality systems
Regulatory compliance
People Management — Mandatory
The role specifically requires line-management experience.
Experience should include:
Leading small to medium-sized teams
Workload management
Coaching and mentoring
Staff development
Performance reviews
Objective setting
Performance feedback
Employee development plans
Succession planning
Project & Resource Management
Preferred experience includes:
Project delivery
Resource planning
Workload forecasting
Capacity planning
Risk management
Stakeholder communication
Meeting project timelines and quality requirements
Data & Reporting Skills
Experience with:
Metric generation
Management reporting
Data analysis
Trend identification
Continuous improvement
Dashboards
Business updates
Strong proficiency in Microsoft Excel, PowerPoint, and Word is expected, along with reporting/analytics tools.
Communication & Stakeholder Management
The candidate should be able to:
Communicate effectively with clients and senior management.
Work with cross-functional teams and external stakeholders.
Deliver presentations.
Lead meetings.
Conduct training sessions.
Influence stakeholders at different organisational levels.
Additional Responsibilities
Experience supporting the following is valuable:
Recruitment
Employee onboarding
Employee development
Audits and inspections
Quality improvement initiatives
Regulated-environment operations
Ideal Candidate Profile
This position is best suited for an experienced Pharmacovigilance professional who has moved beyond individual case processing into team leadership and operational management.
The strongest profile would combine:
PV expertise + people management + resource/capacity planning + regulatory knowledge + metrics/reporting + stakeholder management.
Important Eligibility Point
Unlike the Drug Safety Physician position you shared earlier, this ICON role does not require an MBBS or physician license.
A B.Pharm/M.Pharm or relevant Life Sciences qualification can meet the educational requirement, provided the candidate has strong PV experience and, importantly, mandatory line-management/team-leadership experience.
For someone from an M.Pharm + Pharmacovigilance background, this is therefore a much more relevant target role than the Drug Safety Physician position.
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