Pharmacovigilance Project Lead

Pharmacovigilance Project Lead - Office Hybrid - Warsaw, Poland or Sofia, Bulgaria

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Profile Summary:

The Pharmacovigilance Project Lead provides leadership of pharmacovigilance services in conjunction with an ICON Project Manager for full-service projects. In this client facing role, the Pharmacovigilance Project Lead may also manage projects with single service, small volume, & limited scope complexity Safety Standalone projects. The Pharmacovigilance Project Lead works with oversight from a Project Manager and is assigned to Pharmacovigilance projects throughout all phases of ICON's project's lifecycle to completeness, with a customer-focused approach, and audit and inspection ready mindset. The Pharmacovigilance Project Lead will be able to demonstrate & communicate knowledge of ICON Pharmacovigilance Services and demonstrate key project management skills pertaining to scope, time, budget and quality outcomes.

This job role is office-based in Sofia, Bulgaria or Warsaw, Poland. It requires 60% office attendance and offers flexibility for 40% remote work.

Job Description:

1. Is the Single Point of Contact (SPOC) for the contracted Pharmacovigilance activities and assists Project Manager for project operation oversight.
2. Provide oversight and direction of all Pharmacovigilance services/activities throughout the duration of a project (including deliverables and finances) as a Pharmacovigilance subject matter expert.
3. Primary liaison for client and project team for Pharmacovigilance services/activities (time, scope, cost, quality, resource) matters with oversight from the Project Manager.
4. Conducts regular functional project team briefing meetings to ensure team understanding for the project requirements, key decisions and important updates.
5. Actively communicates with the client and represents Pharmacovigilance operations in teleconferences with the relevant stakeholders for the assigned projects.
6. Responsible to support Pharmacovigilance Project set-up.
7. Ensure up to date team training throughout lifecycle of the project.
8. Responsible to provide Pharmacovigilance Service input into the Project Management Plan throughout the lifecycle of the project. When assigned to a portfolio, ensures consistency of the PMP and safety documentation across all projects.
9. Responsible for the development of project specific plans (i.e. Safety Management Plan).
10. Ensures delivery of high-quality Pharmacovigilance work by the project team with compliance to the agreed timelines.
11. Ensures adherence to company document filing standards and performs regular project file reviews to confirm inspection readiness.
12. Proactively identifies, resolves/mitigates risks through ongoing review of project progress and metrics and escalates risks and/or issues until resolution.
13. Conducts safety presentations for bid defense, start-up meetings, Investigator Meetings and other meetings as needed.
14. Provide guidance for any audit/inspection activities.
15. Monitor quality and compliance for safety deliverables and provides data metrics for inclusion in monthly project reports. Additionally assist management, as required with weekly and monthly project status reports.
16. Lead the coordination of any safety or medical information related activities.
17. Train/mentor newly hired Pharmacovigilance staff, on project specific task as requested.
18. Perform other activities as identified and requested by Pharmacovigilance management.
19. May assume the role of the Pharmacovigilance Project Manager for safety standalone projects that are single service, small volume, & with limited scope complexity with oversight from Sr./Pharmacovigilance Project Manager as applicable.
20. Ensures that Standard Operating Procedures (SOPs), policies and guidelines are adhered to at the project level. Ensure assignment of project specific training to project team.
21. Leads and directs cross-functional team leads/managers and third parties/vendors with some supervision and support. Ensure team is familiar with client and project scope.
22. Guides and supports the project team-leads in prioritizing, trouble-shooting and contingency planning to ensure tasks are carried out in budget, on time and with quality by the project team.
23. Leads and facilitates client and internal project meetings and responsible to approve meeting agenda and minutes. Ensure inclusion of applicable topics, actions and action item follow up.
24. Monitors quality and compliance for safety deliverables and creates monthly project reports for senior leadership and client.
25. Manages & delivers assigned projects per fully executed contract, on schedule and on budget.
26. Establishes project timelines for key milestones and deliverables and communicates project-specific priorities with the project team and monitors status for follow through.

Job Requirements:

1. Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree or certification in pharmacovigilance is a plus.
2. Proven experience in pharmacovigilance or drug safety, with a strong understanding of case processing, safety reporting and regulatory requirements in clinical trial development.
3. Strong leadership and project management skills, with experience overseeing complex pharmacovigilance projects and managing clients and cross-functional teams.
4. Excellent analytical and problem-solving abilities, with a track record of driving improvements in safety monitoring processes.
5. Effective communication, presentation, and interpersonal skills, with the ability to collaborate with diverse stakeholders and manage multiple priorities in a fast-paced environment.
6. Excellent command in English (both verbal and written).

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 maximize 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.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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, color, 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 or submit a request here.

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.

Are you a current ICON Employee? Please click here to apply.