Senior Pharmacovigilance Associate
Posted 5 days ago
Posted 5 days ago
This is a fully remote position, open to applicants in China.
• Operate within a sponsor-dedicated framework, leveraging ICON’s extensive global expertise.
• Oversee and manage pharmacovigilance operations.
• Facilitate the collection, evaluation, and processing of adverse event reports, adhering to regulatory guidelines and corporate policies.
• Perform data analysis and interpretation of safety information, identifying trends and potential safety signals.
• Prepare and submit periodic safety update reports (PSURs) along with other regulatory documentation.
• Collaborate with medical and clinical teams to evaluate the clinical significance of reported adverse events and contribute to risk management efforts.
• Ensure the maintenance and integrity of pharmacovigilance databases.
• Provide guidance and mentorship to junior team members.
• Participate in regulatory audits and inspections to guarantee pharmacovigilance compliance.
• A Bachelor’s degree in a relevant scientific discipline or healthcare-related field.
• Substantial experience in pharmacovigilance or drug safety, with a solid understanding of applicable regulations and industry standards.
• Demonstrated capability to effectively manage the pharmacovigilance process, including adverse event reporting and signal detection.
• Strong analytical and critical thinking abilities, with the capacity to interpret complex data and provide informed recommendations.
• Excellent communication and interpersonal skills, enabling collaboration across cross-functional teams.
• Proficient in pharmacovigilance databases, data management systems, and the Microsoft Office Suite.
• Ability to operate independently and juggle multiple priorities in a dynamic environment.
• Willingness to travel as needed (approximately 15%).
• Legal authorization to work in the country where the position is located.
• Competitive base salary complemented by performance-related incentives.
• Health and wellness programs, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life insurance and disability coverage.
• Employee assistance programs and wellness resources.
• Learning and development opportunities via structured training and career pathways.
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