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About the Role
As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities, ensuring quality and efficiency.
Responsibilities
- Prepare and review safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards.
- Collect and analyze adverse event data from clinical trials and post-marketing sources to support the preparation of comprehensive safety reports.
- Maintain up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting.
- Collaborate with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.
- Ensure the timely submission of safety reports to regulatory authorities and sponsors, adhering to established deadlines and guidelines.
Requirements
- Bachelor's degree in life sciences, pharmacy, or a related field.
- Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements.
- Excellent attention to detail and organizational skills, with the ability to prepare and review complex safety reports accurately.
- Strong communication and collaboration skills, with experience working effectively within a multidisciplinary team.
- Ability to manage multiple tasks and prioritize effectively in a fast-paced, regulated environment.
- Willingness to travel as required (approximately 10%).
- Must have the legal right to work in the country where the role is based.
Skills
- Pharmacovigilance
- Drug safety
- Safety reporting processes
- Regulatory requirements
- Attention to detail
- Organizational skills
- Communication skills
- Collaboration skills
- Multidisciplinary team collaboration
- Task management
- Prioritization
Location
- Tokyo
- Osaka
Work Type
- Office Hybrid
- Remote
Experience Level
- Relevant pharmacovigilance and drug safety experience
Education Level
- Bachelor's degree in life sciences, pharmacy, or a related field
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
About the Company
- ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
- As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Equal Opportunity
- ICON is an equal opportunity employer.
- We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
- If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.