Senior Pharmacovigilance Associate

Senior Pharmacovigilance Associate, Hybrid - Mexico (Mexico City only)

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 Associate to join our diverse and dynamic team. As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities. You will collaborate with cross-functional teams to ensure compliance with regulatory requirements and to maintain the highest standards of patient safety.

What You Will Be Doing:

• Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.

• Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.

• Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.

• Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.

• Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.

• Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.

• Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.

• Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization.

Your Profile:

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. An advanced degree is preferred.

• +3 years extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards.

• Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.

• Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations.

• Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.

• Fluent in written and verbal English

• Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite.

• Ability to work independently and manage multiple priorities in a fast-paced environment.

• Commitment to maintaining confidentiality and handling sensitive patient information with discretion.

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.  All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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