Senior Drug Safety Associate

Overview

As a Sr Drug Safety Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for client marketed products and clinical trials.
• Completion of the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions.
• Perform case processing (including case deactivations) and data gathering tasks within Argus Safety Database and other client systems (i.e. EDC systems).
• Assist with literature review and article procurement as required.
• Perform retrospective quality review and document findings, and contribute to metric compilation
• Assist with business partner and other query management.
• Represent Pharmacovigilance on project teams.
• Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes.
• Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources) as required.
• Train and mentor case processing staff.
• Assist with creating procedures (SOPs, Job Aids), forms and templates in support of efficient case management processes.
• Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
• Other responsibilities, as required.

Qualifications

You are:

• Minimum of 4 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
• Bachelor’s degree in a science or healthcare related discipline (nursing/pharmacy preferred
• Proficiency using safety database systems (Argus experience preferred).
• Advanced knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
• Excellent computer skills (i.e. Microsoft Word, Excel, Outlook, and Power Point).
• Excellent ability to work effectively within a team environment.
• Advanced organizational, time management, and problem-solving skills.
• Ability to create and deliver presentations.
• Excellent verbal and written communication skills.
• Fluency in written and verbal English.
• Travel (domestic and global) 10%
• Ability to travel to office for monthly departmental meetings at assigned Incyte offices as well as for ad hoc meetings and/or urgent matters (notice period: 24 hours or less) as needed.

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 maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt 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, colour, 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.