Offer summary

Qualifications:

Bachelor's degree in a relevant field such as life sciences or healthcare., Strong understanding of ICH GCP guidelines and regulatory requirements., Experience in safety reporting and data management., Excellent communication and interpersonal skills..

Key responsabilities:

Review and track Serious Adverse Event (SAE) data and prepare reports.

Coordinate with project teams and clients to ensure compliance with safety protocols.

Provide safety training and maintain knowledge of relevant SOPs and regulations.

Notify regulatory authorities and prepare regulatory reports as needed.

About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Reviewing, entering, and tracking SAE data, crafting narratives, and coordinating follow-ups and reporting for assigned projects.
Adhering strictly to corporate policies, SOPs/WPDs, and maintaining awareness of ICH GCP guidelines along with relevant global and local regulations.
Interfacing effectively with Project Teams, Client Companies, and Investigators to ensure seamless SAE activities.
Understanding assigned study-specific budgets and applying this insight to your work.
Notifying expedited safety reports to Regulatory Authorities, Ethics Committees, and Principal Investigators within regulatory timelines.
Providing project-specific safety training to PPD or equivalent experience Clinical for assigned projects.
Performing detailed SAE/AE triage and ensuring accuracy in data entry, report tracking, and communication.
Coding adverse event terms and drafting narratives according to client conventions.
Assisting in the preparation and review of regulatory reports and processing adverse event reports from literature.
Maintaining up-to-date knowledge of PPD and client SOPs and regulations.
Communicating effectively with team members, client contacts, and adverse event reporters to successfully implement solutions.

Required profile