Pharmacovigilance Reporting Associate

Pharmacovigilance Reporting Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Senior Pharmacovigilance Reporting Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Reporting Associate at ICON, you will be essential in ensuring accurate and timely reporting of safety data related to pharmaceutical products. You will work closely with cross-functional teams to enhance the organization’s pharmacovigilance reporting processes and maintain compliance with regulatory standards.

What You Will Be Doing:

- Preparing and submitting adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness.
- Collaborating with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals for further investigation.
- Assisting in the preparation of periodic safety update reports (PSURs), annual reports, and other regulatory documents to ensure compliance with reporting obligations.
- Monitoring timelines for safety report submissions and proactively managing any delays or issues that may arise in the reporting process.
- Maintaining and updating pharmacovigilance databases, ensuring the integrity and quality of safety data through meticulous data entry and validation.
- Providing training and support to junior team members on reporting procedures and pharmacovigilance regulations to enhance team capabilities.
- Engaging in audits and inspections by regulatory authorities, ensuring readiness and adherence to all relevant pharmacovigilance reporting requirements.
- Staying informed about changes in regulatory guidelines and industry standards to ensure ongoing compliance and best practices in pharmacovigilance reporting.

Your Profile:

- Bachelor’s degree in life sciences, pharmacy, or a related field. An advanced degree is preferred.
- Extensive experience in pharmacovigilance or drug safety reporting, with a strong understanding of relevant regulations and guidelines.
- Proven ability to prepare and submit accurate adverse event reports and safety data in a timely manner.
- Strong analytical skills, with the ability to interpret safety data and identify trends or issues requiring further action.
- Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
- Proficiency in pharmacovigilance databases and reporting tools, as well as Microsoft Office Suite.
- Ability to manage multiple projects and priorities in a fast-paced environment while maintaining attention to detail.
- Commitment to maintaining confidentiality and handling sensitive patient information with discretion.

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What ICON can offer you:

- Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
- In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
- Our benefits examples include:
- Various annual leave entitlements- A range of health insurance offerings to suit you and your family’s needs.- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.- Life assurance- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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