Remote Pharmacovigilance Officer - Global Patient Safety

Placements24; Klerksdorp; A distancia; ZAR 420.000 - 660.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global EAP LifeWorks access

Life assurance

Flexible country-specific benefits

Descripción de la vacante

ICON Strategic Solutions seeks a Central Review Coordinator to join the Central Review Services team, contributing to independent endpoint data evaluation, grading, and data management for major sponsor projects. You will interact with sponsors, therapeutic experts, and internal teams to ensure timely CR reviews and data integrity.

The role emphasizes collaboration within a unique central review process within the CRO industry, offering career development and global project exposure.

Formación

• BSc Life Science degree with CRO/pharma exposure.
• Experience with data management systems such as Rave.
• Strong written and verbal communication skills.
• Excellent time management and prioritization abilities.

Responsabilidades

• Create and maintain Study Trackers.
• Monitor screening deadlines and follow up with sites on data entry.
• Review study visits and sweeps readiness for CR review.
• Create, send and process reviewer assignments and query tracking.
• Prepare files for patient profiles and post to Central Grading Portal.

Conocimientos

Communication skills

Attention to detail

Time management

Team collaboration

Educación

BSc Life Science degree

Herramientas

Rave

Microsoft Word

Microsoft Excel

Descripción del empleo

Central Review Coordinator

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

This role as Central Review Coordinator offers the right candidate the opportunity to join the Central Review Services team; which is unique in the CRO industry. The team is solely focused on delivering independent, centralized endpoint data evaluation, grading, and data management for one of our Big Pharma FSPs. This central review process produces a higher level of accuracy and decreased variability that is essential in endpoint measurement and analysis.

Responsibilities include:

• Create and maintain Study Trackers.
• Monitor screening deadlines; follow up with sites on data entry and other vendor data entry and elevate any visits that are not released for CR review or where queries are not being addressed within the timelines.
• Review and determine on study visits and sweeps are ready for review using the page status and query reports.
• Create, send and process assignments to reviewers, including query tracking.
• Download and compile files for the patient profile creation and post on the Central Grading Portal for the Data Programmer, CRS.
• Create internal CRS agenda and meeting minutes for distribution.
• Action/Decision log updates/maintenance.
• Filing of documents in Central Grading Portal and eTMF.
• Liaise with Directors, Therapeutic Expertise, internal team members and Sponsors.
• Performs proficient reviews of study datasets prior to client transfer, if applicable.
• Monitor review progress to meet timelines, identify issues, risks, possible solutions & report to Lead Central Review Manager.
• Participates in database lock activities.
• Serve as CR Coordinator on more or more projects.
• #LI-JF1
• #LI-remote

You will have/be:

• BSc Life Science degree with solid experience working within a CRO and or the pharmaceutical industry.
• A genuine interest in using your clinical experience to develop your career in clinical data.
• Strong experience with at least one of the data management systems i.e. Rave.
• Experience in most study tasks.
• Comfortable working within a project team and have excellent written and verbal communication skills.
• Experience in Microsoft Word and Excel.
• Strong attention to detail.
• Effective time management and prioritization skills.

What ICON can offer you:

• 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.

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.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request.

Are you a current ICON Employee?