BRA - Pharmacovigilance Reporting (Associate & Senior Associate) -
Employer:
ICON Plc
Location:
Brazil, Homeworking
Salary:
Competitive
Start Date:
28 Mar 2025
Closing Date:
27 Apr 2025
Job Details:
ICON plc, a world-leading healthcare intelligence and clinical research organization, is seeking a Pharmacovigilance Reporting Associate/Senior Associate (Leader role) to join its diverse and dynamic team.
Location:
Sao Paolo, Brazil (office-based an average of 3 days per week)
Position Overview:
As a Pharmacovigilance Reporting Associate/Senior Associate at ICON, you will be responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. You will ensure compliance with regulatory requirements and contribute to the effective management of safety data to support patient safety and regulatory compliance.
Key Responsibilities:
Preparing and reviewing safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards.
Collecting and analyzing adverse event data from clinical trials and post-marketing sources to support the preparation of comprehensive safety reports.
Maintaining up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting.
Collaborating with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.
Ensuring the timely submission of safety reports to regulatory authorities and sponsors, adhering to established deadlines and guidelines.
Requirements for Associate Role:
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.
Requirements for Senior Associate Role:
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.
Experience leading projects or studies.
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.
What ICON Offers:
ICON offers competitive benefits, including:
Various annual leave entitlements.
A range of health insurance offerings for you and your family.
Competitive retirement planning options.
Global Employee Assistance Programme (LifeWorks) for 24-hour support.
Life assurance.
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, gym memberships, subsidized travel passes, and health assessments.
Diversity and Inclusion Commitment:
ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If you need reasonable accommodation due to a medical condition or disability, please submit a request.
Apply Now:
If you're interested in the role, but unsure if you meet all of the requirements, we encourage you to apply. You may be exactly what ICON is looking for.
Are you a current ICON Employee? Please click here to apply.
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