EVERSANA
EVERSANA
EVERSANA जीवन विज्ञान सेवाओं से जुड़ी एक कंपनी है, जो दवा और स्वास्थ्य सेवा संगठनों को उत्पादों को बाज़ार में लाने तथा उनके वाणिज्यिक प्रदर्शन को बेहतर बनाने में सहायता करती है। इसका काम सलाहकार सेवाओं और प्रबंधन परामर्श, नियामक परामर्श, रोगी सेवाओं, बाज़ार तक पहुँच, मूल्य निर्धारण और राजस्व प्रबंधन, चिकित्सा मामलों तथा डिजिटल रूपांतरण तक फैला हुआ है। उद्योग विशेषज्ञता को डेटा और विश्लेषण के साथ जोड़कर EVERSANA दवा के व्यावसायीकरण में सहायता करती है, जिसमें लॉन्च की योजना, उत्पाद वितरण, मूल्य निर्धारण, रोगी अनुपालन और पहुँच रणनीतियाँ शामिल हैं। कंपनी जीवन विज्ञान क्षेत्र की जटिल चुनौतियों से निपटने के लिए कृत्रिम बुद्धिमत्ता और विश्लेषण का भी उपयोग करती है।

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.

विवरण

  • 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.

आवश्यकताएँ

  • 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.

लाभ

  • The company is Great Place to Work certified.
  • The company is an Equal Opportunity Employer.
  • The company is committed to diversity, equity and inclusion.

संबंधित नौकरियाँ

EY
Jerry
Bose Corporation

Senior Finance Manager, Global Supply Chain

Bose Corporation

Lead financial planning and analysis for Bose’s global supply chain, overseeing P&L, forecasts, and performance reviews. Partner with operations leaders and guide a small analyst team across supply chain functions.

खोलें
Intrepid Travel

Finance Manager, Uzbekistan

Intrepid Travel

Oversee budgeting, compliance, payroll, and financial reporting for Intrepid Travel’s Central Asia operations. Maintain accurate ledgers and support business planning in Tashkent.

खोलें
Runpod

Finance Manager, Infrastructure Capacity

Runpod

Lead financial planning for GPU fleet capacity, utilization, infrastructure investment, and cash needs. Your analysis will help Runpod’s AI developer cloud align capacity decisions with revenue growth.

खोलें
PayJoy

Senior Country Controller, Mexico

PayJoy

Lead PayJoy’s Mexico accounting, financial reporting, compliance, and controls for its emerging-market credit platform. Oversee statutory filings, audits, consolidation, and the local finance team.

खोलें
RTX

Senior Finance Manager, CUAS

RTX

Lead finance for RTX’s CUAS international and strategy portfolios in a senior role supporting aerospace and defense programs. Oversee forecasts, estimates at completion, earned value, proposals, and strategic decision support.

खोलें
Remote Choice

Remote Finance Manager, UK Dental Group

Remote Choice

Lead financial control, reporting and cash management for a growing UK dental group. Support practice profitability, budgeting and sustainable growth.

खोलें
Dent Wizard International

Remote Accounting Manager (Ohio) at Dent Wizard

Dent Wizard International

Lead financial reporting, month-end close, audits, and internal controls for Dent Wizard’s automotive reconditioning business. Manage the general ledger team and improve accounting processes.

खोलें
Procter & Gamble

Senior eCommerce Leader, Direct-to-Consumer

Procter & Gamble

Lead digital commerce, data, CRM, and technology for P&G’s Nature’s Best and Lamberts brands. Grow direct-to-consumer sales and consumer engagement through secure, data-led marketing.

खोलें