Pharmacovigilance, Compliance

Are you ready to lead with impact in Pharmacovigilance? Join us as a PV Compliance 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

• Perform PV Compliance related tasks systematically and effectively while complying with PV related local regulations, procedural documents, and job aids.
• Interface directly with internal PV and non-PV subject matter experts, including the PV responsible staff in the Affiliates, PV case management, PV case processing vendors and CROs and other company  partners, including Quality Assurance and Regulatory Affairs.
• Ensure PV audit and inspection readiness, as well as compliance with all applicable worldwide pharmacovigilance regulations.

• Perform root case analysis (RCA) pertaining to ICSRs submitted late to health authorities, CROs and business partners.
• Perform data entry of RCA conclusions into the global safety database.
• Perform QC of data.
• Manage excel based spreadsheet RCA tracking tool.
• Manage weekly/bi-weekly meetings with case processing vendor(s) to discuss and resolve RCA.
• Attend periodic Compliance team meetings, teleconferences, and/or project team meetings with globally located colleagues.
• Support PV, including local affiliate staff, before, during and after, internal audits and external Health Authority inspections, local affiliate audits, license partners audits and local PV inspections, including onsite support if required and co-located.
• Participate in project improvement activities.
• Maintain timely and effective communications among cross-functional PV team members, vendors, and business partners.

#LI-MC6
#LI-Hybrid 

• 4-year degree (Bachelors)
• Minimum of 6 years in pharmaceutical, biotechnology, or related industry,
• Minimum 4 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.