Job Advert Posting

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities (Safety):

• Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures

• Conducts literature surveillance in the selected database(s) as outlined in the project scope of work and as per established procedures

• 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 for case processing

• Assist with generation of regulatory reports as necessary to ensure regulatory compliance.

• Liaise with other ICON departments, investigational site, reporter, and/or Sponsor as necessary regarding safety issues

• Assist with coordination of interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities)

• Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.

• Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines.

• Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.

• Serve as Functional Lead on case processing or medical information projects as assigned; coordinates teams of Pharmacovigilance associates on project level and serves as the Pharmacovigilance point of contact for project teams.

• Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.

• Generates data listings from the safety database and assumes responsibility for accuracy of the data.

• Supports analysis and quality control during the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports).

• Supports Safety Scientist in signal detection and risk management activities.

• Supports interim data analysis for DMC reviews.

• Participates in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings.

• Reports project status (including monthly metrics) to project/functional management within agreed upon timelines.

• Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.

• Proposes solutions for procedural and technical issues.

• Supports audits and inspections as required for the assigned projects.

• Serves as subject matter experts for case processing and/or medical information tasks in a project team.

• Perform other activities as identified and requested by management, including but limited to:

• Respond and process medical information inquiries, including inquiries related to adverse events/reactions and product complaints for Clients’ product(s), as per their agreement with ICON.

• Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.

Requirements:

• Experience in Pharmaceutical/CRO environment

• At least 3 year of experience in the pharmacovigilance area

• Excellent verbal and written communication skills

• Detail-oriented

• Fluent in written and verbal English

• Excellent organizational and time management skills

• Ability to work effectively independently and within a team environment and across global teams.

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, 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 through the form below.

#LI-FP1

#LI-Hybrid