[Remote] Safety Administrator, Serbia/ Bulgaria at Thermo Fisher Scientific

Serbia

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Healthcare, Life SciencesIndustries

Requirements

Bachelor's degree
Previous experience that provides the knowledge, skills, and abilities to perform the job (advantageous)
Firm knowledge of medical terminology
Ability to effectively delegate tasks and ensure successful completion
Ability to gain clear agreement and commitment from others through persuasion and influence
Effective presentation skills
Ability to provide constructive feedback and suggest improvements to the administrative process
Ability to assist in the management of a large project and to provide work direction and training to others

Responsibilities

Coordinates the timely review of protocol inquiries, triage of abnormal lab alerts and diagnostics; tracks all necessary data and generates reports for the client, project team and/or external vendors
Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams
Liaises with various internal function groups to implement projects, ensuring contractual obligations are met and timelines are achieved
Manages project specific training in collaboration with the Project lead/manager, PSC, PV Lead, and the Project specific training team, including the application of training within the learning management system
Manages the set-up, maintenance and archival of program files within CRG’s electronic filing system; ensuring PV remains audit ready by both identifying and resolving issues
Identifies and redacts subject identifiers per local requirements, recommends site retraining to clinical team and escalates reoccurrences to the organization's Data Privacy
Performs data entry into internal/external databases, tracking systems and performs system reconciliations to identify issues which may negatively impact project timelines
Performs filing within various eTMF systems, both internally and externally, completing file review, uploading of documents, verifying expected documents, and utilizing different eTMF plans/TOCs/guides
Maintains regional Medical Monitor Calendar
Supports Medical Monitor Management with MM resourcing
Performs manual tracking of PADFs, PIFs, and eligibility as needed/contracted
Maintains SAE Review tracker for Medical Monitor only studies; including pertinent case-related information
Supports any specific activities performed by the local office, which cannot be performed from elsewhere
May provide training to junior staff

Skills

Key technologies and capabilities for this role

project coordinationsafety supportprotocol inquiriesmedical monitoringdata trackingreport generationmeeting facilitationmeeting minutesclient liaisoncontractual documents

Questions & Answers

Common questions about this position

What is the work location for this Safety Administrator role?

The position is based in Serbia or Bulgaria.

Is this a remote position?

This information is not specified in the job description.

What are the essential functions of this role?

Key responsibilities include coordinating protocol inquiries and lab alerts, facilitating project meetings, liaising with internal teams, managing training and program files, performing data entry and reconciliations, and handling eTMF filing.

What is the employment type and work schedule?

This is a full-time position with a first shift (days) schedule in an office environment.

What salary or compensation does this role offer?

This information is not specified in the job description.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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