[Remote] Global Medical Safety Lead (client-dedicated), EMEA at Thermo Fisher Scientific

Serbia

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical Research, HealthcareIndustries

Requirements

MD required
History of an active medical license highly preferred
Clinical experience in having direct responsibility for diagnostic and treatment decisions (2+ years)
Direct experience in medical safety/pharmacovigilance (implied from role context)
Strong scientific and analytic skills
Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment
Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams
Excellent presentation skills with the ability to communicate complex issues clearly

Responsibilities

Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting
Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s)
Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s)
Contribute to the development of the overall safety governance structure and activities
Provide safety strategies and deliver accurate, timely and high-quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)
Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
Provide medical safety support for the preparation of responses to regulatory authority inquiries, assuring that safety information is timely, complete, and accurate
Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
Oversee the medical assessment of individual case safety reports (ICSR)
Confirm criteria and content for expedited reporting and unbinding (e.g. SUSAR or urgent safety issues)
Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
Provide medical safety contributions at internal audits and regulatory inspections
Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
Support adverse event reporting training and pharmacovigilance awareness activities cross functionally
Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners
Participate in cross-functional teams and initiatives

Skills

safety signal management

benefit-risk assessment

aggregate safety data review

safety governance

cross-functional leadership

stakeholder collaboration

Regulatory Affairs

clinical development

medical affairs

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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