Safety Administrator

2+ years

Not Disclosed

Remote

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Adverse Event Coordinator (Literature Team)

Work Schedule

Type: Standard (Mon-Fri)
Environmental Conditions: Office-based

Purpose

As an Adverse Event Coordinator within the Literature Team at our organization, you will play a crucial role in coordinating the review of serious and non-serious adverse events, tracking necessary data, and generating reports. You will work closely with various internal and external teams to ensure the timely and accurate completion of tasks related to adverse events and literature management.

Key Responsibilities

Adverse Event Management:
- Coordinate the timely review of both serious and non-serious adverse events, ensuring all necessary data is accurately tracked.
- Generate and distribute reports related to adverse events for the client, project team, and external vendors.
Literature Team Coordination:
- Represent the organization's Literature Team during literature-related meetings, both virtual and in-person.
- Coordinate logistics for meetings and assist with facilitation, ensuring effective communication between the client, third-party vendors, and the project team.
Project Implementation & Management:
- Interface with internal and external parties to implement projects, reviewing all contractual documents for accuracy and ensuring proper internal and external approvals.
- Coordinate and facilitate project meetings, draft meeting minutes, and distribute materials via client portals.
Training & Documentation:
- Oversee the management of project-specific training, ensuring that all training is completed and documented appropriately.
- Ensure the setup, maintenance, and archival of program files, keeping the organization audit-ready at all times.
Compliance & Data Privacy:
- Redact subject identifiers as per local data privacy requirements and retrain staff as needed.
- Escalate any reoccurrences to the organization’s Data Privacy team.
Data Entry & System Management:
- Perform data entry into internal/external databases and tracking systems, ensuring all information is accurate and up-to-date.
- Reconcile systems to identify and resolve any issues that could negatively impact project timelines.
Budget & Expense Management:
- Oversee project expenses, ensuring that the budget remains within established parameters.
- Manage translations and literature article procurement to ensure costs do not exceed the approved budget.
General Coordination & Support:
- Coordinate department functions and provide support for any local office-specific activities that cannot be completed elsewhere.
- Assist with any other duties as assigned by management.
Training & Mentorship:
- Provide training and guidance to junior staff, helping them to develop their skills and ensure that tasks are completed efficiently and in compliance with project requirements.

Requirements

Experience: Experience in project coordination or a related field, preferably in adverse event management or clinical research.
Skills:
- Strong organizational and time management skills.
- Ability to manage multiple tasks simultaneously in a fast-paced environment.
- Attention to detail and accuracy.
- Strong verbal and written communication skills.
- Experience with tracking systems and database management.
Knowledge:
- Understanding of data privacy regulations and adverse event reporting.
- Familiarity with budget management and project tracking systems.
Education: Bachelor’s degree or equivalent experience in a relevant field.

Why Join Us?

By joining Thermo Fisher Scientific, you will be part of a global team committed to advancing clinical research and improving health outcomes worldwide. You will have the opportunity to grow professionally and contribute to innovative projects that make a positive impact on the global healthcare landscape.

For more information and to apply, visit Thermo Fisher Careers.

Equal Opportunity Employer: We are committed to diversity and inclusion. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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Safety Administrator

Job Description

Job Description: Adverse Event Coordinator (Literature Team)

Work Schedule

Purpose

Key Responsibilities

Requirements

Why Join Us?

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