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

• The senior Manager QPPV Office is responsible for the development and maintenance of the Global Pharmacovigilance System Master File (G-PSMF), EU Pharmacovigilance System Master File (EU-PSMF) and non-EU PSMF as required by local legislations.
• Reports to the Director QPPV Office, and contributes to the development, implementation, and successful execution of the GPV mission, objectives and 3-5 year strategic plan.
• Coordinates and oversees the development of strategies, procedures and program management to ensure compliance with all applicable global requirements for the PSMF and EU-QPPV oversight.
• Responsible for implementation of process improvement opportunities to ensure that Global PV represents best-in-class practices, as well as collaborate and support with relevant GPV and non- GPV company partners (e.g., Global Clinical and Research Quality Assurance, Global Regulatory Affairs, Market Research globally, Marketing & Sales functions globally, Business Partner Management globally etc.) for training and alignment with company-wide standards for maintenance of (global) PSMF requirements and QPPV oversight.
• Responsible for the Quality Check of the individual sections and annexes of the PSMF using the PSMF QC checklist and provide valuable feedback to the PSMF stakeholders if applicable.

• Act as subject member expert for the (Global) PSMF and local PSMFs to support audits and inspections and PSMF related projects
• Under the supervision of the Director QPPV Office, responsible for implementation of corrective and preventative actions in relation with the PSMF.
• Is responsible for audit/inspection readiness of Global PV processes and staff in regards to the PSMF and QPPV oversight, and the identification of systemic Quality Risks (trends and patterns) in the Global PV system regarding these global

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• Minimum of 7 years in pharmaceutical, biotechnology, or related industry,
• Minimum 3 years significant experience in Pharmacovigilance, Regulatory affairs or Safety Quality Assurance, including establishing standards in support of the safety quality systems, especially as they impact and influence multiple departments and levels of management.
• Minimum 1 year experience in PSMF implementation and maintenance
• Experience with leading projects, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills
• 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 personal experience and understanding of Process Management, Standards, Training & IT function as they apply throughout the entire pharmaceutical compound/product life cycle
• Computer literacy (including Microsoft Office).

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.