Jobs

  • Job Id: A1734
    Posted: 10-May-2019
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com. Aeternus Solutions Inc. 221 Ruthers Road, Suite 204, North Chesterfield, VA 23235.

Roles and responsibilities:

  • Manage quality and compliance of PV activities including Quality Assurance, Regulatory affairs, and EU QPPV.
  • Lead audit/inspection activities followed by review of CAPA data to identify compliance trends and opportunities for continuous quality improvements (CQI).
  • Develop Key Performance Indicators (KPIs) report(s) and alert Senior GPV Management of deficiencies.
  • Oversee PV training requirements and develop SOP’s WI’s as required.
  • Complete content quality control (QC) review of Pharmacovigilance System Master File (PSMF)
  • Knowledge of US and EU PV regulatory requirements, PV Compliance practices, drug safety databases such as Argus, Emprica trace, ARISg are required.

Required Qualifications:

  • Master’s degree in Pharmacy, Sci (any) or Regulatory Affairs with one year of experience in related occupation.
  • Job Id: A1732
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Maintain knowledge of drug therapy, disease states, pharmacokinetics, FDA regulations and international regulatory reporting requirements, in addition to comprehensive knowledge of coding dictionaries such as MedDRA.
  • Assist in the regulatory submissions as per the CFR (code of federal regulation) involving 21CFR 312 for IND submissions and 21 CFR 314 for NDA submissions.
  • Tracks regulatory submissions in the safety database or project specific trackers.
  • Conduct research to develop methodologies, instrumentation, and procedures for medical application, analyzing data and presenting findings to the scientific audience and public.
  • Assimilate and analyze large quantities of medical data
  • Engage in clinical investigation, research, development, and other related activities.
  • Receive information on adverse events and create case file and initialize received drug safety reports in ARISg database.
  • Generate MedWatch/CIOMS reports to perform quality check/analysis of the processed reports.
  • Extract, analyze, and process adverse event data from all sources for multiple therapeutic areas and multiple clients.
  • Management of case reports for multiple clients in multiple databases, including the preparation of Corrective and Preventive Action (CAPA) reports, which will then be monitored for report outcomes.
  • Evaluate and integrate all case-related information including medical conditions, lab results and procedures as well as compile complete narrative summaries and queries.
  • Apply knowledge of global regulatory requirements to complex cases to ensure the timely submission of accurate and comprehensive reports to worldwide regulatory agencies in accordance with applicable regulations.
  • Interact with reporters, sites, and clients as necessary to obtain clarification or follow-up information and assure that additional data is appropriately integrated into the ICSR and submitted to FDA and regulatory agencies.
  • In the absence of the Operations Manager, monitor case managers to effectively develop, evaluate, motivate, delegate and assess their activities.
  • Perform standard quality control procedures on client cases prepared by other case managers.
  • Oversee case processing throughout, backlog, deliverables and team productivity and quality standards to ensure accuracy and efficiency.
  • Supports departmental process improvement initiatives and collaborates with relevant departments to ensure execution.
  • Assist Quality Department in review and writing of SOPs and WPs, as required.
  • Assist Operations Manager in monitoring resource utilization and adjusting workflow to ensure timely and accurate completion of all tasks.
  • Use Dashboard data to identify sources of inefficiency and propose solutions to optimize operational efficiency.
  • Assist Operations Manager in planning and implementing on-boarding and off-boarding activities for clients.
  • Participate in internal and external audits, responding to any quality issues identified.
  • Maintain regular and relevant multi-directional communication between the ICSR processing team and the client team.

Required Qualifications:

  • Master's Degree in related field..
  • Job Id: A1728
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Designing, developing, configuring and deploying Microsoft Office SharePoint Server applications that include document management, automated workflow, collaboration, messaging, and content management.
  • Developing SharePoint solutions leveraging JavaScript, jQuery, AngularJS, HTML, CSS, XSL and XML, HTML, CSS, C#, and .NET in the creation of custom solutions, including complex workflows or Web parts.
  • Working with Architecture, Engineering, Operations and other groups as appropriate throughout the development and deployment processes.
  • Making informed recommendations pertaining to MS SharePoint information and site architecture, infrastructure, software implementation and web parts design, testing and deployment.
  • Developing custom web parts and integrating enterprise content with SharePoint and business workflows and forms using NINTEX
  • Researching and evaluating alternative solutions and recommending the most efficient and cost-effective solution considering requirements, available SharePoint technology and Governance and Best Practice guidelines.

Required Qualifications:

  • Bachelor’s degree in Information Technology, Computer Science or a related field.
  • Flexible and adaptable in regards to learning and understanding New Technologies.
  • Strong written and oral communication skills.
  • Self-directed and proactive; thinks beyond the immediate problem.
  • Ability to change priorities quickly and capacity to handle multiple tasks or projects.
  • Proven analytical and problem-solving abilities.
  • Job Id: A1729
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Developing tools and process to automate or streamline complex maintenances.
  • Responsible for database clones, moving database instances to different data centers, Renaming database instances.
  • Designing and Onboarding new ServiceNow instances to new customers.
  • Identifying and collaborating with appropriate teams to improve tools and processes such as event monitoring, automation, and the introduction of new tools as required for efficiency.
  • Drive popular problems to resolution with the corresponding internal stakeholders, whilst working on edge cases for implementation-based issues.
  • Using broad knowledge and experience of systems administration and networking principles to proactively prevent and address incidents while constantly improving documentation.
  • Documenting and maintaining relief and resolution guides in knowledge-based articles and standard operating procedures parallel to our scalable and sustainable model.
  • Providing 24*7 on-call support during the on-call schedule.

Required Qualifications:

  • Bachelor’s degree in Information Technology, Computer Science or a related field.
  • Flexible and adaptable in regards to learning and understanding New Technologies.
  • Strong written and oral communication skills.
  • Self-directed and proactive; thinks beyond the immediate problem.
  • Ability to change priorities quickly and capacity to handle multiple tasks or projects.
  • Proven analytical and problem-solving abilities.
  • Job Id: A1730
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Experience in using SharePoint Designer for branding, editing Master Pages/Templates, creating Custom Lists, SharePoint Designer workflows creating Content Types and External Content Types on on-premises SharePoint and Office 365 SharePoint.
  • Experience in developing and deploying custom Web Parts, Workflows, Features, Site Content Types, Lists and Libraries, style sheets and site definitions.
  • Experience in customizing SharePoint pages using C#, .Net, JavaScript, jQuery, AngularJS, CSS.
  • Developed custom workflows and forms using Nintex Workflows, SharePoint designer 2010/2013, InfoPath designer 2010/2013 and Visual studio 2005-2016.

Required Qualifications:

  • Bachelor’s degree in Information Technology, Computer Science or a related field.
  • Flexible and adaptable in regards to learning and understanding New Technologies.
  • Strong written and oral communication skills.
  • Self-directed and proactive; thinks beyond the immediate problem.
  • Ability to change priorities quickly and capacity to handle multiple tasks or projects.
  • Proven analytical and problem-solving abilities.
  • Job Id: A1721
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Actively participate and support the Pharmacovigilance inspection/audit readiness by contributing to preparedness, conduct and deliverables.
  • Maintain and update the Pharmacovigilance System Master File (PSMF) with QPPV and Head of PV.
  • Work in liaison with QA and Regulatory Affairs to ensure appropriate and timely responses submitted to audit and inspection findings.
  • Accountable to ensure appropriate root cause analysis and documentation for pharmacovigilance Deviations and corrective action/preventive action (CAPA) plans.
  • Recommend process development or improvement as needed in Pharmacovigilance department
  • Establish Pharmacovigilance key performance indicators, analyses pharmacovigilance metrics, trend analyses and asses the ongoing pharmacovigilance quality, consistency reporting compliance and operational effectiveness.
  • Initiate and lead interactions with external and internal partners including CROs, Quality Assurance or Regulatory Affairs on developing and aligning strategies and processes related to pharmacovigilance quality and compliance.
  • Maintain oversight of PV SOPs and Working Instructions, assess potential gaps, and identify high-risk areas. Make recommendations for improvements and lead close collaborations with PV subject matter experts on content development and alignment.
  • Monitor the availability and use of the current safety reference documents for ICSR processing, aggregate safety reporting and safety data analyses.

Required Qualifications:

  • Master's Degree in related field.
  • Job Id: A1601
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Responsible for the overall configuration, design, functionality and end-user support of the Salesforce.com platform and Apttus CPQ.
  • Support the implementation of a global Salesforce instance (designated as the One CRM program) and consolidate all business units across the globe onto one CRM platform, integrating with one ERP system, eliminating redundancies, saving money and establishing global processes.
  • Configure and maintain custom objects, record types, fields, page layouts, formulas, data validation rules, triggers, custom workflows, approval processes, installed packages, etc. within Salesforce.com.
  • Maintain user roles and profiles, security settings, access settings, etc. (User Profiles, Role Hierarchy, Sharing Rules and Security).
  • • Responsible for Apttus configuration, pricing, discounting, approvals and quote generation.
  • Collaborate with Business Operations, Information Technology and other business stakeholders to drive high levels of data integrity and operational reliability of our standardized business analytics, tools and processes.
  • Engage with business stakeholders to gather & analyze requirements and propose solutions that leverage Salesforce functionality.
  • Translate approved solutions into actionable deliverables, ensuring high levels of quality, accuracy and process consistency.
  • Exposure to Lightning Experience combines the new Lightning Design System, Lightning App Builder and Lightning Components.
  • Remain current on new and emerging Salesforce functionality and Apttus CPQ/CLM functionality and leverage updates as appropriate to One CRM.

Required Qualifications:

  • Bachelor’s degree in Information Technology, Computer Science or a related field.
  • Flexible and adaptable in regards to learning and understanding New Technologies.
  • Strong written and oral communication skills.
  • Self-directed and proactive; thinks beyond the immediate problem
  • Ability to change priorities quickly and capacity to handle multiple tasks or projects.
  • Proven analytical and problem-solving abilities.
  • Job Id: A1602
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Responsible for monitoring, supporting, and participating in the development and enhancement of the ServiceNow platform.
  • Governance and policy over the ServiceNow tool (meeting once a week to discuss improving governance over ServiceNow).
  • As part of a 24X7 team, perform day to day support and maintenance of the ServiceNow environment configure and improve core and custom applications.
  • Work with process owners to develop business solutions, coordinate support and development efforts within the Admin team.
  • General support, administration and maintenance of ServiceNow platform and associated applications.
  • Work directly with end users to resolve support issues within ServiceNow.
  • Monitor health, usage and overall compliance of ServiceNow and its applications.
  • Develop systems integrations and process automation.
  • Create and configure Business Rules, UI Policies, UI Actions, Client Scripts and ACLs including advanced scripting of each.
  • Create and configure Notifications, UI pages, UI Macros, Script Includes, Formatters, etc.
  • Configuring and managing Discovery and Orchestration.
  • Coordinate application and platform upgrades.
  • Load, manipulate and maintain data between ServiceNow and other systems.
  • Create ServiceNow reports and dashboards.

Required Qualifications:

  • Bachelor’s degree in Information Technology, Computer Science or a related field.
  • Flexible and adaptable in regards to learning and understanding New Technologies.
  • Strong written and oral communication skills.
  • Self-directed and proactive; thinks beyond the immediate problem.
  • Ability to change priorities quickly and capacity to handle multiple tasks or projects.
  • Proven analytical and problem-solving abilities.
  • Job Id: A1603
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Work with scientists and engineers to understand performance characteristics and limits of new design concepts of analytical instruments in the field of proteomics, metabolomics and natural products analysis.
  • Brainstorm engineering solutions and create functional mechanical designs in broad applications ranging from micro- fluidics to robotic mechanisms
  • Develop and analyze proof-of-concept prototype devices using analysis tools such as FEA, CFD and 3-D CAD and help scientists validate new ideas and theories for practical implementation.
  • Provide technical analysis support and guidance to team members and other development groups to implement designs with proven feasibility while ensuring conformance to company and stakeholder requirements.

Required Qualifications:

  • Bachelor’s degree in Mechanical Engineering or a related field.
  • Self-directed and proactive; thinks beyond the immediate problem.
  • Ability to change priorities quickly and capacity to handle multiple tasks or projects.
  • Proven analytical and problem-solving abilities.
  • Job Id: A1604
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Involve in Software Development Life Cycle (SDLC) of Web applications.
  • Responsible for creating different views in workbook to visually analyze data (data –visualization).
  • Responsible for creating MicroStrategy schema and public objects for generating reports using MicroStrategy desktop
  • Responsible for designing, managing, developing, testing, deliver the reports.
  • Play critical role in establishing Best practices for MicroStrategy as wells as Tableau reporting by conducting meeting with the clients for gathering reporting requirements.
  • Involved in gathering requirements for the dashboard from the business executives and prepared the prototype.
  • Worked with data modelers and ETL developers to aid in the design of efficient and robust data structures for reporting and analysis.
  • Interface directly with business customers to understand their process and information needs.

Required Qualifications:

  • Bachelor’s degree in Information Technology, Computer Science or a related field.
  • Flexible and adaptable in regards to learning and understanding New Technologies.
  • Strong written and oral communication skills.
  • Self-directed and proactive; thinks beyond the immediate problem.
  • Ability to change priorities quickly and capacity to handle multiple tasks or projects.
  • Proven analytical and problem-solving abilities.
  • Job Id: A1605
  • Position: Multiple
  • Type: Fulltime/Permanent
  • Please send your profiles to hr@aeternussolutions.com

Roles and responsibilities:

  • Developing software which accomplishes stake holder requirements.
  • Maintaining the existing code base.
  • Testing and production support.

Required Qualifications:

  • Bachelor’s degree in Information Technology, Computer Science or a related field.
  • Flexible and adaptable in regards to learning and understanding New Technologies.
  • Strong written and oral communication skills.
  • Self-directed and proactive; thinks beyond the immediate problem.
  • Ability to change priorities quickly and capacity to handle multiple tasks or projects.
  • Proven analytical and problem-solving abilities.

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