Senior/ Principal Safety Specialist, Czech Republic

Czechia

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent, with at least 2 years of relevant experience. Strong critical thinking and problem-solving skills are essential, along with good oral and written communication abilities, including paraphrasing. A good command of English and the ability to translate information to and from the local language are required, as is computer literacy for working with multiple databases. Previous exposure to Microsoft Office is also necessary.

Responsibilities

The Senior/Principal Safety Specialist will perform day-to-day pharmacovigilance activities within a regulated environment, including monitoring, collecting, translating, disseminating, and tracking safety information. Responsibilities include serving as a regulatory authority contact point, supporting data entry, coding, and assessment of adverse events, and tracking reports and regulatory reporting activities. The role involves collaborating with global teams, assisting in the preparation of procedures, attending meetings and inspections, and mentoring less experienced staff. Additionally, the specialist will review regulatory publications to stay updated on current practices, ensure quality and accuracy of cases, prepare safety reports, and assist with project implementation and coordination.

Skills

Pharmacovigilance

Safety Information Monitoring

Regulatory Reporting

Adverse Event Data Entry

Adverse Event Coding

Adverse Event Assessment

Report Tracking

Translation

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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