Pharmacovigilance Operations Specialist

As a Pharmacovigilance Operations Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Support multiple activities including, but not limited to, the safety document distribution management system, Safety Reporting Plan review, safety database configuration review, MedDRA upgrade, IST/IIRs, post-marketing programs, Market Access/Research programs and all applicable reconciliations.
• Departmental support, including during Audits and Inspections.
• Assist with CAPA/audit or inspection finding investigations and compilation of data to support quality and compliance processes. Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
• Assist with GPRM efforts for initiating new PhVOps projects requiring coordination and set-up of support systems and processes, as required.
• Assist with Pharmacovigilance reconciliation of databases and listings (post marketing and clinical trial sources), as required.
• Assist with reviewing procedures (e.g. SOPs, Working Instructions, Job Aids), forms and templates in support of efficient Project Management.
• Support compliance with internal procedures, regulatory requirements, and business partner agreements to ensure inspection readiness at all times.
• Support and perform case processing activities as needed including but not limited to intake, triage, book-in, data entry, peer/quality review, follow-up and submission
• Maintain files and systems as appropriate.
• Completion of additional tasks and projects as assigned by management.

You are:

• License’s degree in a Science or Healthcare related discipline, or equivalent.
• Minimum of 3 years Pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
• Proficiency using safety database systems (Argus experience preferred).
• General 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).

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/benefits

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. 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-accommodations

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.