Job Title: Pharmacovigilance Reporting Associate
Location: Shanghai, China
Department: Pharmacovigilance
Company: ICON plc
Role Overview:
As a Pharmacovigilance Reporting Associate at ICON, you will play a critical role in ensuring patient safety and regulatory compliance by preparing and reviewing safety reports for clinical trials and post-marketing activities. This position requires attention to detail, knowledge of pharmacovigilance practices, and collaboration with cross-functional teams to ensure timely and accurate reporting.
Key Responsibilities:
Safety Reporting and Data Management:
Prepare and review safety reports, including Periodic Safety Update Reports (PSURs) and Individual Case Safety Reports (ICSRs), ensuring they meet regulatory standards.
Collect and analyze adverse event (AE) data from clinical trials and post-marketing sources to support the creation of comprehensive safety documentation.
Ensure timely submission of safety reports to regulatory authorities and sponsors, adhering to deadlines and guidelines.
Regulatory Compliance:
Stay updated on global regulatory requirements and best practices related to pharmacovigilance reporting.
Ensure all safety reporting activities comply with local and international pharmacovigilance regulations (e.g., ICH, FDA, EMA).
Collaboration and Issue Resolution:
Work closely with cross-functional teams, including clinical operations, regulatory affairs, and data management, to gather information and address reporting issues.
Maintain effective communication and foster collaboration within multidisciplinary teams to streamline reporting processes.
Candidate Profile:
Education and Experience:
Required: Bachelor’s degree in life sciences, pharmacy, or a related field.
Experience in pharmacovigilance or drug safety, with strong knowledge of safety reporting processes and regulatory requirements.
Skills and Competencies:
Exceptional attention to detail and organizational skills for preparing and reviewing complex safety reports.
Strong communication and interpersonal skills for effective collaboration across teams.
Ability to manage multiple tasks and prioritize efficiently in a fast-paced, regulated environment.
What ICON Offers:
ICON prioritizes the well-being and growth of its employees, offering:
Competitive salary and country-specific benefits.
Annual leave entitlements to support work-life balance.
Comprehensive health insurance options for employees and their families.
Retirement planning programs to ensure financial confidence for the future.
Access to the LifeWorks Global Employee Assistance Programme for 24/7 well-being support.
Additional country-specific perks, such as discounted gym memberships, subsidized travel, and childcare vouchers.
Diversity and Inclusion:
ICON fosters an inclusive culture that values diversity and encourages innovation. The company is committed to creating a harassment-free and discrimination-free environment for all employees, ensuring equal opportunities regardless of race, gender, sexual orientation, or other protected statuses.
How to Apply:
If you are interested in shaping the future of clinical development and believe in patient safety above all, this role is for you. Unsure if you meet all the requirements? We encourage you to apply as your skills may be a perfect fit for this or other roles at ICON.
Join ICON and contribute to a healthier world.
Apply Here: Visit ICON Careers
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