Senior Azure DevOps Engineer
Applaudo
Design secure Azure platforms and Terraform automation, supporting Applaudo’s AI-powered products through CI/CD, governance, and cloud infrastructure delivery.
Deschide
EVERSANA este o companie de servicii în domeniul științelor vieții, care ajută companiile farmaceutice și organizațiile din domeniul sănătății să lanseze produse pe piață și să își îmbunătățească performanța comercială. Activitatea sa acoperă consultanța strategică și de management, consultanța de reglementare, serviciile pentru pacienți, accesul pe piață, gestionarea prețurilor și a veniturilor, afacerile medicale și transformarea digitală. Combinând expertiza în industrie cu date și analize, EVERSANA sprijină comercializarea medicamentelor, inclusiv planificarea lansării, furnizarea produselor, stabilirea prețurilor, respectarea tratamentului de către pacienți și strategiile de acces. Compania utilizează, de asemenea, inteligența artificială și analizele pentru a aborda provocări complexe din sectorul științelor vieții.
Senior Business Analyst, Pharmacovigilance AI Systems
Shape requirements for regulated pharmacovigilance platforms and AI systems, supporting validation, user acceptance testing and compliant services for EVERSANA’s life sciences clients.
Descriere
- Gather and maintain platform requirements, including user and functional requirements specifications.
- Create process and data-flow diagrams, user stories, business rules, data dictionaries, interface specifications and non-functional requirements.
- Trace requirements from initial specifications through validation evidence.
- Review requirements with pharmacovigilance operations, Quality, IT Security, Data Privacy and Engineering.
- Oversee change control, coordinate priorities with the Product Owner, and contribute to sprint planning and backlog refinement.
- Define requirements for pharmacovigilance literature, intake, case processing, signal management, aggregate reporting, social media monitoring and compliance modules.
- Specify AI agent roles, inputs, tools, authorized actions, decision authority and human review checkpoints.
- Set AI acceptance criteria, confidence thresholds, monitoring, explainability, auditability, safeguards and fallback behavior.
- Establish model lifecycle governance, evaluation datasets, regression testing and limits on training with client data.
- Convert regulatory, quality, privacy and computer system validation obligations into clear, testable requirements.
- Contribute to validation plans, risk assessments, test strategies and traceability.
- Serve as the requirements contact during audits and regulatory inspections.
- Collaborate with pharmacovigilance operations, medical reviewers, QA, Data Privacy, IT Security, product, UX, data science and engineering teams.
- Support user acceptance testing, coordinate testers, triage defects and verify requirement coverage.
- Develop release notes, functional documentation, training materials and client-facing regulatory content.
Cerințe
- Hold a bachelor’s degree in life sciences, pharmacy, nursing, medicine, computer science or a related discipline.
- Bring at least six years of pharmacovigilance or PV systems experience, including three or more years in business analysis, systems analysis or product requirements for GxP software.
- Have authored user and functional requirements specifications, ideally with validation documents, for pharmacovigilance or regulated life sciences systems.
- Have working knowledge of at least four of the six pharmacovigilance domain areas listed for the role.
- Have hands-on familiarity with a commercial safety database such as Argus, LifeSphere, Veeva Vault Safety or an equivalent system.
- Understand 21 CFR Part 11, EU GMP Annex 11, data integrity principles and GDPR.
- Have experience with a quality management system and formal SDLC processes, including change control, CSV/CSA, traceability and deviation handling.
- Understand LLMs and AI agents in practice, including failure modes and requirements for regulated outputs.
- Prior AI or automation project experience in pharmacovigilance is strongly preferred.
- Demonstrate strong analytical writing skills.
- Be comfortable with Agile delivery and tools such as Jira, Confluence or Azure DevOps.
- Preferred: experience with E2B(R3), MedDRA, WHODrug, EudraVigilance or FAERS.
- Preferred: experience specifying NLP, machine learning or generative AI features, including evaluation metrics and acceptance criteria.
- Familiarity with GAMP 5 second edition and FDA Computer Software Assurance.
- Awareness of the EU AI Act and EMA/FDA AI reflection papers.
- Prior participation in regulatory inspections or client audits.
- Certifications such as CBAP, PMI-PBA or ISPE/GAMP training.
Beneficii
- The company is Great Place to Work certified.
- The company is an Equal Opportunity Employer.
- The company is committed to diversity, equity and inclusion.
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