06 ago
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Ciudad de México
06 ago
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Ciudad de México
Senior 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.
- Location: Mexico City (office-based an average of 3 days per week)
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 to be _Senior A_ssociate_:
- 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.
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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 general 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.
Visit our
careers site
to read more about the benefits ICON offers.
📌 Senior Pharmacovigilance Reporting Associate (Ciudad de México)
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📍 Ciudad de México