Pharmacovigilance Reporting Associate (French/German language) 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.
This role mainly involves Medical Information activities which involve being on phone to the public and Health Care professionals.
The role: • Review and process safety events (pre-marketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures • Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.
• Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products.
• Generates data listings from the safety database and assumes responsibility for accuracy of the data.
• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files* • Perform safety review of clinical and diagnostic data as part of case processing.
• Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
• Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER • Support Qualified Person for Pharmacovigilance as required.
• Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
• Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate.
Requirements: • Background or education in Health Care (Nursing, Pharmacy, Medical) • Fluency in English and, German,or French • Good communication skills 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.
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 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.
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