Are you ready to lead with impact in Pharmacovigilance? Join us as a Data Assurance Lead/ Sr. Manager PV Data Assurance , fully dedicated to one global pharmaceutical sponsor, and play a key role in ensuring data integrity and regulatory excellence in patient safety.IT IS A HYBRID ROLE WITH 3 DAYS IN THE CLIENT OFFICE IN WARSAW

• Provides leadership for the Data Assurance team for operational aspects of individual case safety report (ICSR) and literature global standards and drives quality, consistency and operational efficiency across the PV Case Management functions, regions and case processing vendor(s). Reports to the Medical and Data Assurance Lead and is a member of the Medical and Data Assurance Management Team.
• Responsible for global 1CSR operational quality and consistency within the PV Case Management organization, including work delivered by the case processing vendor(s), which directly impacts the effective management of the safety profile of company development compounds and marketed drugs.
• Leads the Data Assurance team and provides support to the Medical and Data Assurance Lead in liaising with the case processing and literature vendor's operational leads.
• Participates as a member of the Medical and Data Assurance Management Team in the development and successful implementation of the PV Case Management, PV Operations and overall PV vision, mission, objectives and plans associated with operational aspects of ICSR and literature processing.
• Supports inspection readiness activities and fulfils the role of a key SME for topics associated with in-house and outsourced operational aspects of PV Case Management activities for case processing, literature search and assessment.
• Works extensively with ICSR/literature processing vendor personnel to ensure high quality operational data required to support the ongoing assurance of the safety profile of company products. Works with Teams Lead within PV Case Management, PV Operations, other PV functions and non-PY stakeholders (e.g. Medical Affairs, Clinical Science, Development Operations) to ensure alignment with the PV vision.

• Operational quality of ICSRs and associated activities
• Operational leadership
• Data Quality Assurance
• Training and mentoring
• People & Organization Management

#LI-MC6
#LI-Hybrid

• Minimum BA/BS (or equivalent) in life sciences
• Minimum of 8 years relevant experience in general case processing within pharmacovigilance or combined PV/RA/QA, and/or clinical development, including extensive leadership experience and ability to lead and manage global, multidisciplinary teams
• In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations,
• Experience in quality and process improvement activities

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, 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-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.