Thermo Fisher Scientific

FSP Associate Manager, Safety Data and Systems - Pharmacovigilance

Thermo Fisher Scientific • $110K — $130K *
US-AnywhereRemote in North Carolina, US
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in computer science, data science, computational linguistics, applied statistics/biostatistics, life sciences, IT, or related field.
  • 5-7 years of professional experience in IT/Safety/Clinical Research/Pharmacovigilance.
  • Proficiency in Python programming and ML/NLP frameworks.
  • Familiar with GVP/21 CFR 314 concepts, safety database models (Argus/ArisG), and E2B(R3) structure.
  • Experience with deep learning frameworks (e.g., PyTorch, TensorFlow) and transformer-based models.

Responsibilities

  • Design and validate AI/ML and NLP components for safety operations.
  • Contribute to model lifecycle management for safety-relevant AI/ML.
  • Support qualification of AI/ML solutions with regulatory compliance.
  • Serve as key technical resource for Oracle Argus Safety system maintenance.
  • Collaborate with pharmacovigilance and regulatory teams for data management.

Benefits

  • Work-life balance with standard Mon-Fri schedule.
  • Opportunities for professional growth and development.
  • Collaborative and supportive working environment.
  • Focus on employee health and wellbeing programs.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Senior Director, Safety Data and Systems, Global Patient Safety or designee

Job Description:
  • Design, develop and validate AI/ML and NLP components that support safety operations - including MedDRA/WHODrug auto-coding, case triage, duplicate detection and narrative summarization - with clear human-in-the-loop checkpoints
  • Contribute to model lifecycle management for safety-relevant AI/ML: versioning, monitoring, drift detection, retraining and documentation aligned with GxP / GAMP 5 and internal model governance
  • Support the qualification of AI/ML solutions against evolving regulatory expectations (EMA reflection paper on AI, FDA AI/ML guidance, EU AI Act obligations for high-risk systems) in partnership with Quality, DT/BIS and GPS Signal Management
  • 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 safety systems.
  • Assist in system validation, testing, and deployment of safety systems updates.
  • Generate, validate, and customize safety reports and analytics.
  • Collaborate closely with the 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 safety system integrations.
  • Contribute to audit readiness activities, including system inspections, validation reports, and compliance documentation.
  • Collaborates with internal systems team, BIS/ DT and Safety vendor on issues related to Safety data
  • Performs the generation and quality control of aggregate reports and line listings
  • Initiates and contributes to the development of procedural documents including but not limited to Safety Management Plans, SOPs, work instructions, job aides, forms, or templates
  • Collaborates and co-creates with applicable client functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical aspects, setup and operation
  • Keeps up-to-date on applicable regulatory and PV tech guidelines and shares within GPS and client as applicable.
  • Participates in training related to safety data management
  • Proactively reviews processes and tools and provides suggestions for improvement and better efficiencies
  • Complete additional task and projects as assigned by line manager or delegate

Purpose of the role:
  • Apply AI/ML and NLP methods to safety data (not limited to auto-coding, signal management support, narrative summarization, case triage) within GxP-validated, explainable and regulator-defensible frameworks
  • 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 as required for seamless GPS Safety Data and Systems operations


Education and Experience:
  • At least Bachelors' degree (or country equivalent) in computer science, data science, computational linguistics, applied statistics/biostatistics, life sciences / Information technology or other relevant field required.
  • Python, ML/NLP frameworks, model deployment/monitoring, MLOps tooling, ideally exposure to LLMs on unstructured clinical/safety text.
  • Familiarity with, or ability to rapidly acquire, GVP/21 CFR 314 concepts preferred
  • working understanding of safety database data models (Argus/ArisG) and E2B(R3) structure.
  • Relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with 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 of the required skills


In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role
Knowledge, Skills, and Responsibilities:
  • Proficiency in Python for ML development, including scikit-learn, pandas, NumPy; experience with at least one deep learning framework (PyTorch or TensorFlow).
  • Natural language processing for extraction of adverse events, drugs, and outcomes from unstructured text - case narratives, medical literature, call transcripts, and spontaneous reports.
  • Named Entity Recognition (NER), relation extraction, and text classification
  • Experience with transformer-based / large language models (BERT-family, clinical/biomedical models such as BioBERT or PubMedBERT, and modern LLMs) for narrative generation, summarization, and information extraction.
  • MedDRA and WHODrug auto-coding using ML/NLP; prompt engineering and retrieval-augmented generation (RAG) a plus.
  • Supervised and unsupervised methods for classification, clustering, and anomaly detection.
  • Feature engineering and model evaluation (precision/recall trade-offs, ROC/AUC, calibration) with an understanding of why recall and sensitivity are weighted heavily in a safety context.
  • Model lifecycle management: versioning, monitoring, drift detection, retraining pipelines using standard MLOps tooling (e.g. MLflow, Azure ML, Databricks) in line with client DT/BIS standards
  • Model explainability / interpretability (SHAP, LIME) - essential where decisions must be defensible to health authorities.
  • Understanding of GxP / GAMP 5 validation as applied to AI/ML systems, model governance, and emerging regulatory expectations (EMA reflection paper on AI, FDA guidance) - rare and worth flagging as preferred.
  • Proficiency in Safety Database systems (e.g. Argus) and knowledge of other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems) is a plus.
  • Proficiency in electronic systems commonly used for Safety / PV, like for data visualization and analysis, dashboards
  • Solid understanding of the quality management processes, metrics and KPIs
  • Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
  • Proficient in the Microsoft 365 stack (Excel, Word, PowerPoint, Teams, SharePoint, OneDrive) and in modern collaboration and documentation tooling
  • Advanced Excel required; working proficiency in SQL required for querying safety and operational datasets
  • Ability to communicate effectively and collaborate successfully across functions and with vendors
  • Fluent communication in written and spoken English required
  • Ability to work independently with minimal oversight and prioritize effectively
  • Ability to complete multiple complex deliverables within tight timelines
  • Ability to function effectively in a team environment


Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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