Thermo Fisher Scientific

PV Coordinator

Philippines

Not SpecifiedCompensation
Entry Level & New GradExperience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Candidates should possess strong problem-solving skills, the ability to work independently with minimal supervision, demonstrated ability to foster positive relationships, effective in analyzing project-specific data/systems for accuracy and efficiency, skilled in acting as a liaison and communicating diplomatically with clients, management, and team members, self-motivated with a positive attitude and excellent communication skills, proficient in MS Office (Word, Excel, PowerPoint, Access), ability to prioritize tasks and meet strict deadlines, strong attention to detail and meticulous work orientation, a professional demeanor in challenging circumstances, and flexibility to adapt to changing project timelines. Knowledge of FDA Regulations, ICH Good Clinical Practices, and SOPs for non-clinical/clinical project aspects is required.

Responsibilities

The Drug Safety Admin Associate II will coordinate the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board (DSMB) data, track all necessary data and generate flawless reports for clients, project teams, and external vendors, represent the DSMB/EAC Coordination Team at global and domestic committee meetings, coordinating all logistical aspects and assisting with facilitation, collaborate with internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements, ensuring all contractual documents are accurate and approved, compile adjudication dossiers and build/submit follow-ups to investigative sites, coordinate and facilitate project meetings, draft meeting minutes, post blinded and unblinded minutes/materials to client portals, and distribute to project teams, manage project-specific training and the setup, maintenance, and archival of program files, ensuring audit readiness, identify and redact subject identifiers per local requirements, train sites, and bring up reoccurrences to Data Privacy, perform data entry into internal/external databases, tracking systems, and budget management systems; perform system reconciliations to identify potential issues, coordinate expenses and manage translations, ensuring budget parameters are met, answer hotline calls, coordinate department functions, and perform other duties as assigned, support activities specific to the local office that cannot be performed elsewhere, provide training to junior staff.

Skills

Protocol review
Adverse event management
Data safety monitoring
Report generation
Meeting coordination
Contract preparation
Adjudication dossiers
Project management
Data entry
Database management
Budget management
Translation coordination
Data privacy

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.

Key Metrics

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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