Pharmacovigilance Reporting Specialist (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 Reporting Specialist will serve as safety reporting or safety reporting intelligence processor and/or lead for multiple or portfolio safety reporting or safety reporting intelligence stand-alone projects, providing management support as designated while recognizing, exemplifying, and adhering to ICON's values, which center around our commitment to People, Clients, and Performance. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. The incumbent will complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and client processes to ensure accountability of safety reporting or safety reporting intelligence activities on assigned projects or portfolio, working in a customer focused approach and an audit and inspection ready mindset. We are looking for someone able to demonstrate skills pertaining to client management, safety reporting intelligence, project scope, submission compliance, quality, and budget as designated.

This job role is office-based in Sofia, Bulgaria or Warsaw, Poland. It requires 60% office attendance and offers flexibility for 40% remote work. Flexible working hours for the designated locations are in force.
 

Job Description:

• Submission of expedited Serious Adverse Event (SAE) reports, periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during project set-up, within project specified timelines.

• Provides technical and process oversight with respect to safety reporting services on assigned projects.  
• Provides technical and process oversight with respect to safety reporting intelligence services on assignments.  
• Performs oversight of assigned projects or portfolio ensuring all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information or for the release of global safety reporting intelligence requirements.
• Operates in a lead capacity ensuring ownership and accountability of safety reporting activities or safety reporting intelligence on assigned projects.
• Ensures completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
• Serves as support to the Safety Reporting Group management in all aspects of departmental activities, including but not limited to quality and compliance metric review, finance tracking and oversight, project resource tracking, client engagement, training oversight and CAPA oversight as designated.
• Collaborates with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors as applicable. Build and maintain good relationships across functional units.
• Works within multiple databases. Maintenance of project information or safety reporting intelligence information with timely updates to the project or intelligence databases.

• Assist in the development of departmental Standard Operating Procedures (SOPs) and Work Procedures (WPs), as needed.
• Prepare for and represent the department in audits and inspections as designated.
• Effectively coaches and mentors less experienced associates in all aspects of safety reporting or safety reporting intelligence and other work, as needed.
• Review regulatory and safety reporting intelligence to keep updated on current regulations, practices, procedures, and proposals as assigned. 
• Implement and coordinate routine project activities, including presentations at client or investigator meetings, responses to client, authorities, and other stakeholders; review of project requirements and maintenance activities; review, escalation of metrics; and budget considerations as assigned.

Job Requirements:

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

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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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, 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