[Remote] Associate Manager Safety Data and PV Systems (Client-dedicated) at Thermo Fisher Scientific

United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Bachelor’s degree (or country equivalent) in life sciences, Information technology, or other relevant field
Solid knowledge of global (EU/US/Asia Pac) pharmacovigilance requirements and practices
Minimum of 7 years of relevant experience in IT, Safety, Clinical Research, or Pharmacovigilance overall
At least 3 years of proven experience with safety database systems (e.g., ARGUS or ArisG), including workflow management
Equivalent and adequate combination of education and experience or proven practical expertise in all required skills
Good knowledge of relevant pharma (incomplete in description, but implied as pharmacovigilance-related)

Responsibilities

Manage and monitor applicable GPS mailboxes, including unblinded data
Serve as the key technical resource for the configuration, maintenance, and administration of the Oracle Argus Safety system
Support day-to-day operation and troubleshooting of Argus Safety application to ensure reliable and compliant drug safety case processing
Assist in system validation, testing, and deployment of Argus Safety system updates, workflows, and business rules
Generate, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms
Collaborate closely with pharmacovigilance, clinical, and regulatory teams to ensure safety data management aligns with global regulatory standards (FDA, EMA, PMDA, ICH)
Participate in change management processes to enhance Argus Safety system workflows and system integrations
Contribute to audit readiness activities, including system inspections, validation reports, and compliance documentation
Collaborate with internal systems team, BIS, and Safety vendor on issues related to Safety database configurations
Perform the generation and quality control of aggregate reports and line listings
Initiate and contribute to the development of procedural documents, including Safety Management Plans, SOPs, work instructions, job aides, forms, or templates
Collaborate and co-create with applicable client functions (e.g., Medical Information, Data Management, Business Information Systems, Quantitative Science) regarding pharmacovigilance technical aspects, setup, and operation
Keep up-to-date on applicable regulatory and PV tech guidelines and share within GPS and client as applicable
Participate in training related to safety data management
Proactively review processes and tools and provide suggestions for improvement and better efficiencies
Complete additional tasks and projects as assigned by line manager or Head of GPS Operations/designee
Lead deliverables for GPS Safety Data Management and Safety System Maintenance activities
Provide high quality data outputs for Safety Signal Management, Risk Management, and Safety Evidence generation
Collaborate and co-create with client functions and applicable vendors for seamless GPS Safety Data and Systems operations

Skills

Oracle Argus Safety

Safety Data Management

Pharmacovigilance

System Configuration

System Maintenance

Troubleshooting

System Validation

Workflows

Business Rules

Safety Reports

Analytics

Business Intelligence

Risk Management

Safety Signal Management

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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