Senior Pharmacovigilance Associate

Senior Pharmacovigilance Associate- Post-Marketing case processing

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.

Criteria:

• We are looking for an experienced professionals who has 4+ years of case processing experience in Post Marketing Surveillance.

• Education background: B.Pharm / M.Pharm, Pharm.D, BDS, B.Sc Nursing/M.Sc Nursing, BAMS, BHMS

What You Will Be Doing:

• We are looking for an experienced professionals who has 4+ years of case processing experience in Post Marketing Surveillance.
• Experience in ICSR processing for marketed products.
• Knowledge of seriousness, expectedness, causality, and global reporting.
• Familiarity with reconciliation processes and aggregate reporting (PSUR/DSUR).
• Ability to mentor new joiners and review SOPs.
• Working knowledge of SDEA and KPI/SLA basics.
• Process literature ICSRs and maintain compliance with monitoring requirements.
• 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

Your Profile:

• At least 4+ years in case processing with Post-Marketing
• 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:
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply