Position: Senior Pharmacovigilance Reporting Associate
Location: Seoul, South Korea (Hybrid Office)
Job Code: JR128862
Company: ICON plc - Full Service & Corporate Support
About ICON:
ICON plc is a global leader in healthcare intelligence and clinical research, committed to driving innovation and excellence in clinical development. ICON fosters an inclusive and dynamic environment to shape the future of clinical development.
Key Responsibilities:
Adverse Event Reporting: Prepare and submit adverse event reports and safety data in compliance with regulatory requirements and internal policies.
Data Analysis & Safety Signals: Collaborate with clinical and regulatory teams to review and analyze safety data, identifying trends or potential safety signals for further investigation.
Regulatory Documents: Assist in preparing periodic safety update reports (PSURs), annual reports, and other regulatory documents.
Report Submission Management: Monitor timelines for safety report submissions, managing any delays or issues in the process.
Database Maintenance: Maintain and update pharmacovigilance databases, ensuring data integrity through validation and meticulous data entry.
Training & Support: Provide training and support to junior team members on pharmacovigilance regulations and reporting procedures.
Audits & Inspections: Participate in audits and inspections by regulatory authorities, ensuring compliance with pharmacovigilance reporting standards.
Regulatory Awareness: Stay informed of changes in regulatory guidelines and industry standards to maintain compliance and adopt best practices.
Qualifications:
Education: Bachelor’s degree in life sciences, pharmacy, or related field (advanced degree preferred).
Experience: Extensive experience in pharmacovigilance or drug safety reporting with a strong understanding of relevant regulations and guidelines.
Skills:
Strong analytical skills to interpret safety data and identify trends.
Proficiency in pharmacovigilance databases and reporting tools.
Excellent communication and interpersonal skills for cross-functional collaboration.
Ability to manage multiple projects in a fast-paced environment with attention to detail.
Commitment to confidentiality and handling sensitive information with discretion.
Benefits:
Competitive salary and comprehensive benefits.
Annual leave entitlements.
Health insurance tailored to you and your family’s needs.
Retirement planning options to secure your future.
Global Employee Assistance Program (LifeWorks) offering 24-hour support from a global network of professionals.
Life assurance and flexible country-specific benefits (e.g., childcare vouchers, gym memberships, subsidized travel).
To Apply:
Visit the slug link to apply for the role: senior-pharmacovigilance-reporting-associate-seoul-jr128862
Inclusion Statement:
ICON is dedicated to providing an inclusive and accessible workplace, ensuring equal opportunities for all applicants.
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