Jobs

We currently have 3 open positions

Senior/Principal PV/DV Process Consultant (UK)

Job: Senior/Principal PV/DV Process Consultant

Posted: 21-Apr-2021

Department: Insife UK

Qualification: PV systems or business experience, business process focused, workstream lead or project lead experience

Where: Cambridge (or at client, WFH largely accepted)

Insife has recently opened its UK office, and is expanding its strategic consulting as well as technology offerings.  We are looking for our next colleague who is an experienced Senior/Principal PV/DV Process Consultant.  You are an experienced Drug Safety/Pharmacovigilance SME and/or Device Vigilance SME and Consultant, and have expert level of understanding of the processes involved within PV.  You have solid project/workstream lead experience, with strong communication skills.  You are self-driven and would comfortably fit into a high energy, rapidly expanding international organisation, where a healthy portion of change readiness is a must.  Our UK office is located in Cambridge, but most of our work is delivered from home or from the client site, depending on client needs.

Your duties will include:

• Being the Insife lead in the business process workstreams of Insife implementation projects, managing Insife and potentially client or partner resources

• Planning, management and participation in client workshops in the business process elements of Insife projects

• Consultancy to Insife clients, in the subject of PV processes

• Participation in the Insife Global Consulting Practice, in the area of PV business process and process change

Your skill set and experience will include:

• Leading teams to document and re-engineer PV business processes in many of the following areas:

  • Case management

  • Aggregate reporting

  • Signal Detection

  • PSMF management

  • SDEA management

  • Quality and Audit management

  • Device reporting

• Planning, managing and participating in workshops with PV organisations to document and re-engineer PV business processes

• The ability to document PV processes and provide detailed guidance to system implementors

• Experience of managing PV process change within a PV organisation – e.g. analysis of SOP updates, training requirements

If you are interested in working for us, please send your application via email to hr@insife.com with reference to the job posting in the subject.

PV/DV Process Consultant (UK)

Job: PV/DV Process Consultant  

Posted: 21-Apr-2021

Department: Insife UK

Qualification: PV systems or business experience, business process focused, project experience

Where: Cambridge (or at client, WFH largely accepted)

Insife has recently opened its UK office, and is expanding its strategic consulting as well as technology offerings.  We are looking for our next colleague who is an experienced PV/DV Process Consultant.  You are an experienced Drug Safety/Pharmacovigilance SME and/or Device Vigilance SME and Consultant, and have an excellent level of understanding of the processes involved within PV.  You have solid experience within PV business process related projects, with strong communication skills.  You are self-driven and would comfortably fit into a high energy, rapidly expanding international organisation, where a healthy portion of change readiness is a must.  Our UK office is located in Cambridge, but most of our work is delivered from home or from the client site, depending on client needs.

Your duties will include:

• Being the Insife business process consultant in the business process workstreams of Insife implementation projects

• Preparation of and participation in client workshops in the business process elements of Insife projects

• Consultancy to Insife clients, in the subject of PV processes

• Participation in the Insife Global Consulting Practice, in the area of PV business process and process change

• Preparing and delivering business process related training to Insife clients and internal colleagues

Your skill set and experience will include:

• Documenting and re-engineering PV/DV business processes in some of the following areas:

  • Case management

  • Aggregate reporting

  • Signal Detection

  • PSMF management

  • SDEA management

  • Quality and Audit management

  • Device reporting

• Preparing and participating in workshops with PV organisations to document and re-engineer PV business processes

• The ability to document PV processes and collaborate with system implementors

• Experience of participating in PV process change projects within a PV organisation e.g. authoring SOPs, preparing/delivering training

If you are interested in working for us, please send your application via email to hr@insife.com with reference to the job posting in the subject.

PV Technology Expert / Senior Consultant (DK, UK, DE or IN)

Job: PV Technology Expert / Senior Consultant

Posted: 21-Apr-2021

Department: Insife Denmark, UK, Germany or India

Qualification: PV Systems experience, Technology leader, Deep technical focus

Where: Insife office (or at client, WFH largely accepted)

Insife has recently opened its UK office, and is expanding its strategic consulting as well as technology offerings.  We are looking for our next colleague who is an experienced PV Technology Expert/Senior Consultant.  You are an experienced Drug Safety/Pharmacovigilance SME and Consultant, and have deep technical skills in the areas of PV systems technology with experience of leading the technology streams within implementation projects.  You have solid experience within PV IT systems, with strong communication and documentation skills.  You are self-driven and would comfortably fit into a high energy, rapidly expanding international organisation, where a healthy portion of change readiness is a must.  Our offices are located in Copenhagen (Denmark), Cambridge (UK), and Bangalore (India), but most of our work is delivered from home or from the client site, depending on client needs.

Your duties will include:

• Being the technology lead on Insife implementation projects

• Technical consultancy to Insife clients

• Close collaboration with the Insife product development team on system changes

• Business Development activities focusing on PV systems technology

Your skill set and experience will include:

• Being the Technology workstream lead on an implementation project within a PV organisation

• Advanced technical skills in a PV IT system (e.g.  Argus Safety, ArisG, or a bespoke system)

• Expert level knowledge of full stack system development

• Experience with deploying and maintaining software in a GxP environment

• Some knowledge of AI and Machine Learning techniques

If you are interested in working for us, please send your application via email to hr@insife.com with reference to the job posting in the subject.

PV Technology Consultant (DK, UK, DE or IN)

Job: PV Technology Consultant

Posted: 21-Apr-2021

Department: Insife Denmark, UK, Germany or India

Qualification: PV Systems experience, deep technical focus, solution oriented

Where: Insife office (or at client, WFH largely accepted)

Insife has recently opened its UK office, and is expanding its strategic consulting as well as technology offerings.  We are looking for our next colleague who is an experienced PV Technology Expert/Senior Consultant.  You are an experienced Drug Safety/Pharmacovigilance SME and Consultant, and have deep technical skills in the areas of PV systems technology with a focus providing solutions.  You have solid experience within PV IT systems, with strong communication and documentation skills.  You are self-driven and would comfortably fit into a high energy, rapidly expanding international organisation, where a healthy portion of change readiness is a must.  Our offices are located in Copenhagen (Denmark), Cambridge (UK), and Bangalore (India), but most of our work is delivered from home or from the client site, depending on client needs.

Your duties will include:

• Participating in the technology workstream on Insife implementation projects

• Technical consultancy to Insife clients

• Participating in Insife product development projects

Your skill set and experience will include:

• Deep technical skills in a PV IT system (e.g.  Argus Safety, ArisG, or a bespoke system)

• Expert level knowledge of full stack system development

• Experience with deploying and maintaining software in a GxP environment

• Knowledge of AI and Machine Learning techniques

If you are interested in working for us, please send your application via email to hr@insife.com with reference to the job posting in the subject.

PV Consultant/Project Manager (UK)

Job: Project Manager/Senior PV Consultant

Posted: 12-Jul-2021

Department: Insife UK

Qualification: PV systems experience, technology focused, project management experience

Where: Anywhere UK (or at client, WFH largely accepted)

​Insife has recently opened its UK office, and is expanding its strategic consulting as well as technology offerings.  We are looking for our next colleague who is an experienced PV Consultant and Project Manager.  You are an experienced Drug Safety/Pharmacovigilance SME and Consultant, and have a good understanding of related PV technologies e.g. Argus Safety, ArisG databases or similar.  You have solid PM experience, with strong communication skills.  You are self-driven and would comfortably fit into a high energy, rapidly expanding international organization, where a healthy portion of change readiness is a must.  Our UK office is located in Cambridge, but most of our work is delivered from home or from the client site, depending on client needs.

Your duties will include:

• Project management of external Insife client projects, including system implementations - managing Insife and potentially client or partner resources

• Consulting on Insife client projects, including system implementations

• Participation in the Global Insife Project Management practice

• Participation in internal Insife projects e.g. product development

• Business Development support

Your skill set and experience will include:

• Managing medium or large sized projects for PV organizations, including planning and budgeting responsibilities

• Consultancy in the area of PV systems, within a PV organization or a services/software organization

• Management of projects involving multiple workstreams, multiple vendors/partners

If you are interested in working for us, please send your application via email to hr@insife.com with reference to the job posting in the subject.

Validation Lead (India)

Job: Validation Lead

Posted: 12-MAR-2021

Department: Product Development

Where: Noida or Bangalore

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Role Definition:

Experienced with validation of Pharmacovigilance or Drug Safety systems and other products and services in drug safety domain. Well versed with validation planning including but not limited to requirement analysis, risk assessment, test strategy, authoring and execution of test scripts and preparing summary reports.

Responsibilities:

• Validation expertise on Argus Safety, ArisG or other drug safety systems

• Authoring Validation Plan, Traceability Matrix and Validation Summary Reports

• Requirements Analysis, Risk Assessment, Profiling and Mitigation

• Managing complete life cycle of qualification docs like IQ, OQ, MQ, PQ etc.

• Knowledgeable with regulatory guidelines from FDA, EMEA and other regulatory authorities

• Well versed with Defect Management Plan, Change Control Procedure, Document Management Plan and Training Plan

• Experienced in working with clients on product implementations and conduct testing

Essentials:

• 8-12 years of experience in Computer System Validation and System Implementation in the Life Sciences industry

• Well versed with various SDLC models and Software Test life cycle and Defect Management Life Cycle

• Understanding of RDBMS concepts and working knowledge of writing SQL queries

• Comfortable working across time zones for overlap with global clients

• Ability to multi-task and work well under pressure

• Excellent communication and interpersonal skills

Nice to Have Skills:

• Knowledge of Pharmaceutical / Life Sciences/ Drug Safety domain and products

• Knowledge of test automation

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If you are interested in working for us, please send your application via email to , with reference to the job posting in the subject.