Drug Safety Associate 4

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre 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.

Provides management of individual case safety reports (SAEs, ADRs, AEs of special interest and other types), reconciliation of SAEs, coding of safety data, literature surveillance, and data retrievals from the safety database. Supports the generation of aggregated safety reports, and Data Monitoring Committees (DMC) reviews

Accountable for implementation of project/program specific processes to ensuring interim and final contractual deliverables for assigned projects/programs/portfolio and/or Drug Safety service areas are achieved. Includes coordination of contributing project team members and issue resolution with client.

• Ensures accuracy and consistency of safety data processing from receipt from various sources to final output (g. reports, listings, data export).
• Completes first line reviews of complex planning documents for the contracted services (g. Safety Management Plans, SAE Reconciliation Plans, Literature Search Plans) and ensures consistency of those across programs/portfolios and/or service areas.
• Serves as primary escalation point for internal and external team members for risks associated with project/program/portfolio and/or service area
• Identifies operational and/or financial risks in relation to the assigned projects/programs/portfolios and/or service areas and escalates those to the responsible project manager(s)
• Exercises independent judgement to troubleshoot and resolve operational project issues and to identify areas for improveme Serves as primary point of contact for the service area in the absence of the project manager
• Interface with project team members, client contacts and other stakeholders and often serve as project lead to disseminate information to team members.
• Develops and conducts project/program/portfolio and/or service area specific safety training sessions for assigned team members and serves as lead mentor for less experienced staf
• Ensures accuracy and consistency of safety data processing from receipt from various sources to final output (g. reports, listings, data export).
• Completes first line reviews of complex planning documents for the contracted services (g. Safety Management Plans, SAE Reconciliation Plans, Literature Search Plans) and ensures consistency of those across programs/portfolios and/or service areas.
• Serves as primary escalation point for internal and external team members for risks associated with project/program/portfolio and/or service area
• Identifies operational and/or financial risks in relation to the assigned projects/programs/portfolios and/or service areas and escalates those to the responsible project manager(s)
• Exercises independent judgement to troubleshoot and resolve operational project issues and to identify areas for improveme Serves as primary point of contact for the service area in the absence of the project manager
• Interface with project team members, client contacts and other stakeholders and often serve as project lead to disseminate information to team members.
• Develops and conducts project/program/portfolio and/or service area specific safety training sessions for assigned team members and serves as lead mentor for less experienced staf
• Ensures accuracy and consistency of safety data processing from receipt from various sources to final output (g. reports, listings, data export).
• Completes first line reviews of complex planning documents for the contracted services (g. Safety Management Plans, SAE Reconciliation Plans, Literature Search Plans) and ensures consistency of those across programs/portfolios and/or service areas.
• Serves as primary escalation point for internal and external team members for risks associated with project/program/portfolio and/or service area
• Identifies operational and/or financial risks in relation to the assigned projects/programs/portfolios and/or service areas and escalates those to the responsible project manager(s)
• Exercises independent judgement to troubleshoot and resolve operational project issues and to identify areas for improveme Serves as primary point of contact for the service area in the absence of the project manager
• Interface with project team members, client contacts and other stakeholders and often serve as project lead to disseminate information to team members.
• Develops and conducts project/program/portfolio and/or service area specific safety training sessions for assigned team members and serves as lead mentor for less experienced staf

• Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional.
• Must read, write and speak fluent English. Multiple language abilities desirable.
• Advanced knowledge in pharmacovigilance and the regulatory environment governing safety and risk management activities. Experience in leading larger and or global functional project teams.
• Demonstrated ability to provide leadership for teams of drug safety associates, including the planning, supervision, and implementation of processes on a project level.
• Previous experience using computerized information systems and standard application software (Windows, MS Office)
• At least 6 years of experience in pharmacovigilance and or associated service areas
• Pharmaceutical and or CRO experience including leading projects or small operational teams in a specific area.
• Good written and oral communication skills

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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, 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.