Senior Manager Affiliate Operations

Are you ready to lead with impact in Pharmacovigilance? Join us as a Senior Manager PV Affiliate Support  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 operational excellence of the Pharmacovigilance (PV) Affiliate Management (AFM) Function and Governance.
• Responsible for day to day interactions with and guidance of the Company PV Affiliate Drug Safety Officers (DSOs) to ensure Affiliate local PV systems, processes and procedures are compliant and efficient and in line with global/regional regulatory requirements and Company policies and procedures.
• At the same time, drives the global harmonization of processes and procedures.

• Strategy Development and Execution
• Compliance Oversight
• PV Inspections and Audits readiness and CAPAs Corrective and Preventive Action
• Monitoring the Data Quality of the affiliate PV System
• Maintenance of Quality Documents
• Training
• Project activities

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1. Degree in Health Science, Life Science, Medical Science or equivalent by experience (BS/MSc degree or
2. Seven (7)+ years experience within PV or A technical expert or manager with an in-depth understanding of all aspects of pharmacovigilance and related disciplines and a strong industry perspective.
3. Excellent communication and influencing skills to deal with cultural sensitivities and to influence and motivate others. Demonstrate tactfulness, diplomacy and a global mindset.
4. Service orientated and pro-active problem solving
5. Good organizational skills, logical in thought and detail
6. Demonstrate proactive innovative, developing skills and continuously strives for improvement opportunities
7. Awareness of local industry code(s) of
8. Excellent verbal and written English language
9. Ability to work
10. Good understanding of good documentation
11. Ability to work with (company) required IT

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.