Pharmacovigilance, Controlled Documents

Are you ready to lead with impact in Pharmacovigilance? Join us as a PV Controlled Documents Professional  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 Controlled Documents Professional is responsible for contributing to the development and implementation of the overall strategy to ensure excellence in Process and Procedural Document (PD) Management (e.g., Policies, SOP, WI, Job Aids etc.), in compliance with all applicable worldwide pharmacovigilance regulations and company internal and industry standards.
• Coordinates and oversees the development of sustainable business processes and process documentation, to support and improve operational performance, and ensure oversight over and regulatory compliance of, the Pharmacovigilance Quality Management System. Drives the Implementation of a continuous procedural document-improvement process for PV (including any (IT) tools and systems), and compliance with periodic review of documents and appropriate revision.

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• Responsible for global oversight over and coordinating the maintenance of all (global, regional and local) PV procedural documents (e.g. Policies, SOP, WI, Job aids, conventions etc.), including translations into local language as required.
• Responsible for establishing and maintaining methodologies for the management and maintenance of the PV PD structure (PV document pyramid) and road map including maintaining compliance with periodic review of PDs.
• In collaboration with function heads, document owners leads and SME’s, identify deviations in performance from the standards and implement strategies for corrective action to ensure that PV processes and PDs are consistent with regulatory (e.g. GVP, GCP, local PV) requirements, company policies and best-in-class practices.
• Maintain oversight over any identified duplication, discrepancies, conflicts or gaps related to PV PDs, and propose, coordinate and implement changes in collaborations with the process owners and functional management, ensuring the implementation of a continuous quality document-improvement process for PV.
• Proactively monitor the external environment to identify opportunities for improvement, maintain awareness of regulatory issues impacting PV business processes, and support the process owners with implementation of new legislation and initiating changes into quality documents.
• Actively scan the internal environment, and assess any new or revised SOPs or other applicable PDs, whether arising within the affiliates or other company functions, or global documents linking in to the Pharmacovigilance system, for impact on PV PDs.
• Facilitate the development of all cross-functional SOPs, and WIs that involves PV work-related responsibilities. Work closely with colleagues in other departments and within the Global quality network to ensure these processes are documented and maintained.
• Implement strategies, processes, and tools for maintaining records and document archiving per company policy and regulatory requirements.

• 4-year degree (Bachelors)
• Minimum of 2 years’ experience in pharmaceutical, biotechnology, or related industry, including establishing standards in support of the quality systems, especially as they impact and influence multiple departments and levels of management

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.