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Prudentia Group, LLC (Prudentia) is looking for self-motivated, collaborative, dynamic professionals to join our growing team. We have a talented team of professionals who are committed to quality delivery, service excellence, and customer satisfaction. Our culture is open and collaborative and we help our people feel excited and supported throughout their careers with us.Prudentia Group, LLC (Prudentia) is looking for self-motivated, collaborative, dynamic professionals to join our growing team.

No of position: 1

Job Location: Noida

Required Experience and Skills

  • 4+ years’ experience in PV domain
  • Preferrable experience in ARISg/Argus safety database technical knowledge
  • Ensure and maintain quality metrics 95%+
  • Handle server/service/scheduler related issues as per client SOP
  • Understand and develop SQL/PL SQL scripts/procedures
  • Build understanding of user acceptance testing (UAT) and support in UAT executions
  • Lead problem solving sessions
  • Provide timely resolution of service requests
  • Perform safety systems configuration

Skills and Competencies

  • Must have good written & oral communication skills.
  • Timely attend and respond to assigned tasks as per business need
  • Possesses good analytical and reasoning Skills.

Education

  • B.E /B. Tech/ MCA or any related bachelor’s degree

Position: Associate Consultant – QA

No of position: 1

Job Location: Pan India

Responsibilities

  • Interpret, build upon, and comply with organization’s quality assurance standards
  • Implement quality assurance policies and procedures applicable to the organization’s need
  • Plan, conduct and monitor product quality and process efficiency
  • Coordinate internal audits and support audits conducted by clients
  • Coordinate investigation of customer complaints and non-conformance issues
  • Ability to develop, recommend, and monitor corrective and preventive actions
  • Prepare reports to communicate outcomes of quality activities
  • Assure ongoing compliance with quality and industry regulatory requirements
  • QA consultant for CSV activities & release in accordance with organization’s policies. For example:
    1. Author/review of key validation documents like VP, Change Request, Risk Assessment, Trace Matrix, Validation Summary.
    2. Testing: Author/Review/Execution of IQ, OQ, PQ
    3. Test Defect Management

 Technical Skills

  • 1-3 years of experience in QA (in Pharmacovigilance preferable)
  • Experience in Quality Management Standards like ISO 9001
  • Experience in Software Quality Assurance
  • Experience in Computer System Validation (CSV)
  • Good knowledge of CSV principles like GAMP, PIC/S
  • Good knowledge of various regulatory requirements like US FDA, EU, MHRA etc. for CSV and Quality Assurance.
  • Good knowledge of Software Development Life Cycle

Soft Skills and Competencies

  • Must have good written & oral communication skills.
  • Strong analytical and problem-solving skills
  • Good decision-making skills and customer focus
  • Great team player with the ability to work with minimal supervision

Education

  • B.E /B. Tech/ MCA/B. Pharm/M. Pharm or any related bachelor’s degree

Job Location: Pan India

Required Experience and Skills

  • 5+ Years’ experience in BO/Cognos Reports and PV domain (Mandatory)
  • Experience in developing and implementing reports based on client specifications
  • Experience in deploying BO, creating Universe and setup of Framework Model in Cognos
  • Good knowledge in creating Webi, Desktop reports in BO and Report studio, Query studio in Cognos
  • Understanding business requirements and documentation
  • Good knowledge in Central Management server of BO and Framework Manager in Cognos
  • Experienced in creating Database/Data source and customize Reports.
  • Experienced in RDMS and writing SQL/PLSQL.
  • Good with Analytics, Troubleshooting skill, dashboards

Skills and Competencies

  • Possesses good analytical and reasoning skills.
  • Must have Knowledge of Pharmacovigilance domain and Drug Safety Systems
  • Must have good written & oral communication skills.

Education

  • BE /B. Tech/ MCA or any related bachelor’s degree.

No of position: 2

Job Location: Noida: Work from Office

Required Experience and Skills

  • 2 – 7 years of experience in .NET Core.
  • Proficient in Database Knowledge
  • Expertise with Angular

Skills and Competencies

  • Excellent troubleshooting and communication skills.
  • Timely attend and respond to assigned tasks as per business need.
  • Possesses good analytical and reasoning skills.

Education

  • B. Tech/ BCA/MCA or any related bachelor’s degree

No of position: 2

 Job Location: Pan India

 Experience Required: 6-9 Years of Experience (PV is a must)

Roles and Responsibilities:

  • Act as SME for Computer System Validation (CSV) for GXP based computerized systems developed internally and deployed for customer implementations.
  • Work closely with cross functional groups, including Design, Development and Business Analysts to deliver
  • Define risk-based validation strategy & execute in line with Prudentia QMS (Quality Management System)
  • Participate in assessments including System impact assessment, functional risk assessment, data integrity assessments etc.
  • Manage End-to-End System Testing Life Cycle (STLC), like: Define test strategy, build test scenarios as necessary based on criticality of requirements.
  • Testing effort estimation and resource management.
  • Manage test execution.
  • Perform CAPA (Corrective and Preventive Actions) and RCA (Root Cause Analysis) for test incidents and deviations.
  • Review and reporting Test Results in line with System Testing Life Cycle.
  • Participate in end-to-end change management including handling deviations both during the project and operation phase.
  • Author and peer review of key validation documents, as per Good Documentation Practices. Validation documents such as
    Validation Plan
    Change Request
    Risk Assessment Report
    Test Plan
    Test Scripts: IQ, OQ, PQ/UAT
    Test Incident Reports
    Trace Matrix
    Test/Validation Summary

Required Experience and Knowledge:

  • Good knowledge of CSV and SDLC concepts: V-Model, Waterfall, Agile Scrum etc.
  • Exhibit good understanding of regulations/guidelines applicable to Life sciences/Pharma industry like GAMP, GxP, GDP, 21 CFR Part 11, EU Annex 11, GDPR etc.
  • Knowledge of Pharmacovigilance (PV) computer systems (Preferred)
  • Sound knowledge of validation of GxP systems (on cloud / on premise solutions).
  • Hands on with Validation deliverables like:
    URS
    FRS
    Risk Assessment
    Configuration specifications
    Validation Plan
    IQ/OQ/PQ Test scripts (authoring/review/execution),
    Trace matrix & Validation Summary report.

Skills and Competencies

  • Excellent troubleshooting and communication skills
  • Timely attend and respond to assigned tasks as per business need.
  • Possesses good analytical and reasoning skills.

Education

  • Tech/ BCA/MCA or any related bachelor’s degree

No of position: 2

Job Location: Pan India

Experience Required: 3-7 Years of Experience (PV is a must)

Roles and Responsibilities:

  • Responsible for scoping, planning and supporting the successful implementation of solutions by providing business analysis, best practice research, detailed requirements and user acceptance testing.  Solutions may involve system implementation or upgrades, data migration, custom reporting, and system integration.
  • Act as a liaison between business, development, and testing teams.
  • Support project planning by defining required tasks and effort estimate.
  • Lead/facilitate internal and/or client team workshops and meetings.
  • Author business process documents such as SOPs, Work Instructions, process maps, and training materials
  • Conduct training on business process and system functionality.
  • Author system requirements such as User/Functional Requirements Specification
  • Support end-to-end validation for a project by developing test scenarios traced to requirements, authoring and executing test scripts to confirm business process and validate system functionality.
  • Conduct impact assessments against business process and corresponding systems for change requests.
  • Incorporate regulatory requirements into process definitions and user/functional requirements.
  • Review project deliverables for adherence to documentation standards.
  • Assess process and technology issues, develop workarounds, and design solutions.  Compare solutions and develop business case for the appropriate solution.
  • Impart trainings to new hires, colleagues, and peers.

Required Experience and Knowledge 

  • Has drug safety and pharmacovigilance domain knowledge including experience with ARISg and/or Argus safety databases.
  • Has strong problem-solving skills to investigate and propose solutions for complex requirements or issues.
  • Exhibits strong soft skills typically required as a Business Analyst e.g., active listening, challenging the status quo, ability to communicate complex information, issues, and potential solutions to stakeholders.
  • Demonstrates leadership in assignments and is able to engage a team towards ambitious goals.
  • Proficient in using Microsoft application such as PowerPoint, MS Excel (spreadsheets, charts, pivot tables), MS Word, MS Visio, and MS Project.
  • Proficient in using Sharepoint applications such as “lists” for implementing trackers and RAID logs.

Education

Advanced degree in computer science, life sciences, or engineering.

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