Senior Pharmacovigilance Associate

Senior Pharmacovigilance Associate- LSMV Database skills

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:

• We are looking for an experienced professionals who has 4+ years of case processing experience, including strong LSMV skills.
• This role involves leading efforts to collect, evaluate, and process adverse event reports, making sure all reporting is accurate and submitted on time according to regulatory and company standards.
• You will analyze safety data carefully, interpret findings, and identify trends or potential safety issues that need further investigation.
• Responsibilities also include preparing and submitting detailed periodic safety update reports (PSURs) and other regulatory documents while adhering to international compliance requirements.
• You'll work closely with medical and clinical teams to determine the clinical importance of reported adverse events and support risk management initiatives.
• Maintaining and ensuring the integrity of pharmacovigilance databases is essential, along with upholding documentation quality and compliance with data management protocols.
• The position also entails training and mentoring junior staff in pharmacovigilance procedures, regulatory standards, and industry best practices.
• Participation in audits and inspections by regulatory authorities is required, with a focus on maintaining readiness and full compliance.
• Remaining up to date with changing regulations and industry advancements is vital to continually improve pharmacovigilance processes within the organization.

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Your Profile:

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field. An advanced degree is preferred.
• At least 4+ years in case processing with LMSV skills
• 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.
• 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.

What ICON can offer you:

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

At ICON, inclusion & belonging are fundamental to our culture and values.   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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