ICSR Management Liaison Manager

Are you ready to lead with impact in Pharmacovigilance? Join us as a ICSR Management Liaison Manager 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 Regional PV Process ICSR Management Interface. Reports to the Lead Regional PV Process ICSR Management Interface, and contributes to the successful execution of the GPV objectives and 1-3 year operational plan, supporting the overall GPV mission.
• Responsible for regulatory compliance of regional (outsourced) activities. Works extensively with PV process staff within the region as well as with regional or assigned global license partners and company Global Development Organization, Medical Affairs and local Drug Safety Officers to ensure alignment with GPV’s vision and that these interactions directly support the ongoing assurance of the safety profile of company products.

• ICSR Processing (Individual Case Safety Report)- Ensure PV requirements are incorporated in protocol design for interventional as well as non-interventional studies and Market Research Programs and/or Safety Management Plans for clinical studies or organized data collection progrems conducted in (assigned) region

• Product Quality Complaint Management- Build and maintain close relationships with QA, Regulatory Affairs, Product Supply and Manufacturing functions in assigned region

• Quality, Data Assurance & Business Information management- Oversee Regulatory compliance and QC of outsourced activities and implement business regulatory compliance and inspection readiness requirements in cooperation with regional PV Process assigned license partners

• Vendor & Outsourcing Management- Build and maintain collaborative relationships with regional or assigned global license or co-developmental partners and Contribute to joint development of strategies to continuously improve deliverable quality. Serve as liaison between the regional PV Process organization and other company functions, License Partners and the vendor(s)

• People & Organization Management- Works extensively with relevant internal and external stakeholders, particularly with Business Partner Management for license partner communication and SDEA contents.

#LI-MC6
#LI-Hybrid

• Minimum BA/BS in life sciences
• Minimum of 5 years relevant experience in the pharmacovigilance or combined PV/RA/QA, and/or clinical development
• 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
• In-depth knowledge and understanding of PV Process regulatory requirements and guidelines in assigned region
• Proven experience with (GxP) Qualities Management
• In-depth understanding of PV, data management and adverse event reporting and

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.