Manager Medical Assurance

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

• Contributes to ensuring the quality of (contracted) work delivered under the PV Case Management function, specifically global ICSR medico-scientific quality and consistency, which directly impacts the effective management of the safety profile of development compounds and marketed drugs
• Works with vendor medical 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. Works with PV Operations Team members, Product Responsible Persons (PRPs) and non-PV stakeholders (e.g., Medical Affairs, Medical Science, Development Operations, Data Management) to ensure alignment with the PV vision
• Leads projects on behalf of the Medical Expert Team to establish and utilize effective systems to house regulatory documentation and support tools relevant for medical assessment case processing activities (including but not limited RSI, Medical Concept Library and EPTLs).
• Serves as Secretariat for the RSI Process Oversight Committee, responsible for committee meeting agenda and logistics; preparing and distributing all meeting materials; scheduling and conducting the meetings (periodic and ad-hoc); preparing and distributing minutes; and ensuring actions are followed up and completed

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• Responsible for overseeing the daily management of the central mailbox by the Medical Expert Team through triaging, direct handling and distributing urgent and routine requests to relevant team members. Correspondence includes e.g., potential safety issues originating from ICSRs, new/updated reference safety information and associated documents, product trainings and any question/request from company PV/non-PV stakeholders or vendor staff pertaining to the medico-scientific aspects of ICSR or literature and associated processes and tools.
• Contributes to creating and maintaining global standards, conventions, and processes for medical review and assessment of ICSRs and literature, including expectedness, seriousness, causality, event selection, MedDRA coding, case narrative, company comment and medically related follow-up queries.
• Builds and maintains collaborative partnerships with case/literature processing vendor medical managers and PRPs and Medical Safety Group Leads and Team Leads, as well as non-PV staff across e.g., Medical Science, Development Operations, Medical Affairs and Data This includes but is not limited to monitoring the timely communication of potential safety issues, managing Reference Safety Information (RSI) for development compounds and marketed drugs in PV Case Management, and providing a point of escalation and final decision making.

• MSc degree in life sciences, or equivalent
• General case processing experience and expertise within Pharmacovigilance
• Minimum of 5 years relevant experience in 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
• Ensures case processing and case quality are maintained at the highest standards at all times
• Demonstrates an ability to proactively predict and resolve complex problems

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.