Job Information
ICON Clinical Research Pharmacovigilance Reporting Associate in Sofia, Bulgaria
Pharmacovigilance Reporting Associate
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.
The PV Reporting Associate serves as safety reporting intelligence processor, and may lead safety reporting intelligence stand-alone projects, providing management support as designated.
With responsibility for safety reporting intelligence activities on assigned activities, they will be working with a customer focused approach and an audit and inspection ready mindset.
The role :
• Maintain safety reporting requirements for expedited and periodic reports, line listings, for Regulatory Authorities, Ethics Committees, and investigators within specified timelines as well as other Pharmacovigilance intelligence as per assignment and in accordance with company procedures.
• Maintain a strong understanding of ICON's Pharmacovigilance intelligence systems, processes, and conventions
• Maintain a strong understanding of ICON Standard Operating Procedures (SOPs), Working Procedures (WPs), guidance documents and manuals associated with Pharmacovigilance intelligence.
• Perform oversight of assigned projects ensuring all ICON, Sponsor, and regulatory timeframes are met for the maintenance of related global safety reporting intelligence requirements.
• Operate in a lead capacity ensuring ownership and accountability of safety reporting intelligence on assigned projects.
• Ensure completion of all assigned project activities accurately and in accordance with ICON standards, regulatory requirements, and client contractual obligations.
Collaborate with various parties such as project team members and client contacts as applicable. Build and maintain good relationships across functional units.
• Work within multiple databases. Maintenance of Pharmacovigilance intelligence information with timely updates to the intelligence databases.
Travel (approximately 10%) domestic and/or international, as required.
What you need:
Requirements:
• Bachelor's degree in life sciences
• 4 to 6 years of experience on a similar position in pharmacovigilance
• Fluency in English language
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