Job Information
ICON Clinical Research Senior Pharmacovigilance Reporting Associate in Sofia, Bulgaria
Senior Pharmacovigilance Reporting Associate - Office with Flex - 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 Summary:
The Senior Pharmacovigilance Reporting Associate will prepare, perform quality checks of, and submit expedited and periodic reports for all types of safety events and other medically related project information. The incumbent will serve as safety reporting and/or pharmacovigilance intelligence lead for multiple safety reporting and/or pharmacovigilance intelligence stand-alone projects, providing management/project management support as designated and in-depth expertise regarding all aspects of safety reporting.
The position is office hybrid (60% office-based / 40% homebased) open for our offices in Sofia, Bulgaria and Warsaw, Poland.
Job Responsibilities:
• 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 study set-up, within study specified timelines.
• Maintain a strong understanding of ICON's safety reporting systems, processes, and conventions, as appropriate.
• Maintains a comprehensive understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with safety reporting.
• Operate in a lead capacity ensuring ownership and accountability of safety reporting activities on assigned projects.
• Collect, monitor, assess, evaluate, research, and track safety reporting information.
• Coordinate and perform adverse event data entry, coding, and assessment of adverse events as needed, case review, follow-up, reportability assessment, tracking of reports and regulatory reporting activities.
• Review cases entered for quality, consistency, and accuracy, including review of peer reports.
• Collaborate with various parties such as project team members, client contacts, investigators, adverse event reporters, and third-party vendors. Build and maintain good relationships across functional units.
• Work independently to receive, triage, manage and reconcile adverse event reports, in accordance with contractual and regulatory timelines.
• Work within multiple databases. Maintenance of project information and timely updates to the project databases.
• Perform quality control of documents submitted to the eTMF ensuring file readiness on assigned projects for audits or inspections.
• 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.
• Support and train less experienced staff in all aspects of safety reporting and other work, as needed.
• Review regulatory and pharmacovigilance intelligence to keep updated on current regulations, practices, procedures, and proposals.
• Maintain medical understanding of applicable therapeutic area and disease states.
• 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.
• Participate in client and internal meetings, representing the Safety Reporting department for the assigned projects.
• Participate in departmental activities aimed at improving process and efficiency.
• Perform any other activities as assigned by management.
Requirements:
• Health science degree.
• At least 4 years of experience in Pharmacovigilance.
• Knowledge of GCP and regulatory requirements.
• CRO experience and past experience with regulatory reporting is a plus.
• Project lead experience is a plus.
• Advanced English (writing, listening and speaking).
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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 (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 or submit a request here (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.
Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply