Are you ready to lead with impact in Pharmacovigilance? Join us as a Manager, 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

• Responsible for development and maintenance of excellence in Data Assurance, with a focus on 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).
• Responsible for ensuring the quality of (contracted) work delivered under the PV Case Management and regional function, which directly impacts the effective management of the safety profile of development compounds and marketed drugs.
• Works extensively with vendor personnel and PV Case Management staff within and across the regions to ensure the high data quality required to support the ongoing assurance of the safety profile of products.
• Ensures complete and accurate processing of individual safety case reports for all products. Globally over 150.000 case versions are processed annually with an average annual increase of appr. 15%.

• Strategy Development and Execution

- Leads and oversees the Data Assurance regional team in order to support global policies and standards to ensure case consistency and quality at the operational level.

• ICSR Processing & Literature Management

                - Creating and maintaining conventions, tools and processes for non-medical review and assessment of ICSRs and literature, including case intake, data entry (including the case narrative), unblinding, quality control and monitoring, when performed by the case processing vendor(s).

• Quality, Data Assurance & Business Information management

              - Represents Data Assurance in Inspections, PV audits and non-PV audits (GMP/GCP) as an SME on case quality matters  

• Trainings

              - Responsible for training and specialist education of Vendor and PV Case Management staff in assigned region.

• People & Organization Management

              - Contribute to the effective implementation of optimal organizational structure(s) which maximizes on the use of resources, taking the global impact into consideration, and reflects business needs and conditions. Develops an environment to enable each member of Data Assurance function to optimally operate in the matrix environment of PV .

#LI-MC6
#LI-Hybrid

• Minimum BA/BS, preferably with an advanced professional degree
• Minimum of 5 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development, including extensive leadership experience, including ability to lead and manage a 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
• Proven experience with establishing and maintaining (GxP) Qualities Management System.
• In depth personal experience and understanding of Process Management, Standards &Training as they apply throughout the entire pharmaceutical compound/product life cycle

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.