Pharmacovigilance, QMS

Are you ready to lead with impact in Pharmacovigilance? Join us as a PV QMS, 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 the development and maintenance of excellence in global PV Audit and Inspection management and Process Improvement, to ensure oversight over the PV Quality Management System, ensuring inspection readiness, as well as compliance with all applicable worldwide pharmacovigilance regulations.
• Ensure oversight over the compliance, consistency, and quality of Pharmacovigilance processes by performing internal audits, deviation investigations and driving continuous improvement of the PV System, so that PV represents best-in-class practices.
• Collaborate with PVQA and relevant PV and non-PV company partners in support of global PV Audit and Inspections.

• Support and/or host PV audits (internal and partners) and regulatory inspections, including onsite support if required and co-located.
• Ensure coordination and support within PV (before, during and after) for external audits & inspections.
• Prepare PV staff for internal audits and external regulatory inspections.
• Support PV staff in local affiliate audits, license partner audits and local PV inspections.
• Support creation and execution of the PV Non-conformance/CAPA system.
• Provide guidance to the PV functions on the development, implementation and evidence collection required to address non-conformances.
• Conduct regular internal assessments of PV processes for continuous improvement.
• Implement best practices in audit / inspections management in close collaborations with Global and regional Quality Assurance functions.
• Analyze audit/inspection findings and work with impacted stakeholders to identify appropriate corrective and preventive actions.
• Coordinate and support effectiveness checks, performed for applicable CAPAs, including following up on progress.

#LI-MC6
#LI-Hybrid

• 4-year degree (Bachelors)
• Minimum of 5 years in pharmaceutical, biotechnology, or related industry,
• Minimum 3 years significant experience in Pharmacovigilance, Regulatory Affairs or Quality Assurance, including establishing standards and metrics in support of quality systems.

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.