Pharmacovigilance Supervisor

Why This Role Matters

Patient safety is the foundation of clinical research and pharmaceutical development. Pharmacovigilance ensures that adverse events are properly monitored, assessed, and reported in compliance with global regulatory standards. Effective safety oversight not only protects patients participating in clinical trials but also safeguards public health after products reach the market.

The Supervisor – Pharmacovigilance role at ICON plc is central to maintaining high standards of drug safety reporting and regulatory compliance. This position directly influences the accuracy, timeliness, and integrity of adverse event reporting while leading a team responsible for critical safety operations.

For professionals with strong pharmacovigilance experience and leadership capabilities, this role offers the opportunity to contribute to global clinical development programs within a world-leading healthcare intelligence and clinical research organization.

Job Description

ICON plc is seeking a Supervisor – Pharmacovigilance to join its dynamic and diverse team. The selected candidate will oversee day-to-day pharmacovigilance operations related to clinical trials and marketed products. The role involves supervising safety reporting processes, ensuring regulatory compliance, managing submission workflows, and guiding the pharmacovigilance team to maintain best-in-class reporting standards.

The Supervisor will collaborate with cross-functional departments including clinical operations, regulatory affairs, and quality teams to optimize safety reporting systems and maintain compliance with global pharmacovigilance regulations. This position requires strong technical knowledge, leadership skills, and the ability to manage multiple safety workflows simultaneously.

Key Features of the Role

Leadership opportunity within global pharmacovigilance operations.
Exposure to clinical trial and post-marketing safety reporting.
Direct interaction with regulatory authorities and global compliance frameworks.
Collaboration with cross-functional global teams.
Career progression within a leading clinical research organization.

Responsibilities Required

Supervise day-to-day pharmacovigilance safety reporting operations, ensuring timely and accurate submission of adverse event reports to regulatory authorities.
Oversee safety case processing, medical review coordination, and submission tracking in accordance with global regulatory timelines.
Ensure compliance with international pharmacovigilance regulations, guidelines, and internal standard operating procedures (SOPs).
Manage safety submissions workflow and ensure proper documentation, quality checks, and audit readiness.
Collaborate with clinical operations, regulatory affairs, and quality assurance teams to streamline safety reporting processes.
Provide leadership, mentoring, and training to pharmacovigilance team members to ensure adherence to best practices.
Monitor performance metrics and implement process improvements to enhance reporting efficiency and compliance.
Support regulatory inspections and audits by preparing required documentation and addressing safety-related queries.
Ensure accurate maintenance of safety databases and tracking systems.
Identify potential compliance risks and implement corrective and preventive actions (CAPA) where required.
Maintain high standards of data accuracy, confidentiality, and regulatory integrity across all pharmacovigilance activities.

Qualifications

The ideal candidate will possess a strong academic background in life sciences or pharmacy, combined with practical pharmacovigilance and leadership experience.

Educational Requirements:

Bachelor’s degree in Life Sciences, Pharmacy, or a related field.

Experience and Skills:

Solid experience in pharmacovigilance or drug safety, particularly in clinical trials and/or post-marketing surveillance.
Strong knowledge of global pharmacovigilance regulations and reporting guidelines (e.g., ICH, FDA, EMA frameworks).
Experience supervising or mentoring pharmacovigilance team members.
Strong understanding of safety database systems and submission workflows.
Excellent communication and organizational skills.
Ability to manage multiple priorities and ensure compliance with strict regulatory timelines.
High attention to detail and commitment to data accuracy.
Ability to work effectively in a cross-functional and global team environment.

Salary Insights

Compensation will be competitive and aligned with global CRO industry standards for supervisory-level pharmacovigilance professionals. The overall package may include performance-based incentives and country-specific benefits aligned with experience and role responsibility.

Additional benefits may include:
Competitive salary structure
Health insurance options for employees and families
Retirement planning benefits
Life assurance coverage
Global Employee Assistance Programme (LifeWorks)
Flexible, country-specific optional benefits such as childcare vouchers, gym memberships, and travel subsidies
Generous annual leave entitlements

Company Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to advancing clinical development and improving patient outcomes. The company operates globally, supporting pharmaceutical, biotechnology, and medical device clients in delivering high-quality clinical research solutions.

ICON fosters a culture of inclusion, innovation, and excellence, providing professionals with opportunities to grow within a diverse and performance-driven environment. The organization is committed to maintaining a workplace free from discrimination and promoting equal opportunity for all employees.

FAQs

1. Is supervisory experience mandatory for this role?
   Yes, prior experience in leading or mentoring pharmacovigilance teams is highly preferred.

2. Does this role focus only on clinical trials?
   The role covers both clinical trial safety reporting and post-marketing surveillance activities.

3. What regulatory knowledge is required?
   Strong knowledge of global pharmacovigilance regulations such as ICH guidelines and regulatory authority requirements (e.g., FDA, EMA).

4. Are cross-functional collaborations involved?
   Yes, the role requires close coordination with clinical operations, regulatory affairs, and quality teams.

5. What is the primary objective of the role?
   To ensure accurate, timely, and compliant safety reporting while leading pharmacovigilance operations effectively.

Application Tips

Highlight your pharmacovigilance experience, especially supervisory or leadership responsibilities.
Mention regulatory frameworks and safety databases you have worked with.
Provide examples of managing submission timelines and regulatory compliance.
Demonstrate experience handling audits or inspections related to safety reporting.
Be prepared to discuss real-world pharmacovigilance workflow management scenarios during the interview.