Celgene Senior Manager/ Associate Director CH Case Management Operations in BOUDRY, NebraskaSwitzerland

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Purpose:

Provide leadership and support for UK based Case Management Team

Ensure effective co-ordination of AE flow through the case management workflow in coordination with Swiss based team

Ensure process conformity with applicable regulations and Celgene standards and ICSR conventions

Establishment, maintenance and monitoring of key performance indicators (KPI)

Drive Case Management process enhancement and team development

Case Management Operations Performance, Metrics & Resourcing

  • Lead goal setting, Key Performance Indicators (KPIs) development

and performance management within the GDSRM International Case

Management Operations team

  • Support central and where applicable affiliate resource calculation

and contribute resourcing strategies including hiring and supervision

of temporary contract staff

  • Liaison with HR Business Partners service providers including

resourcing for temporary staff

  • Establish team metrics to support resourcing and contribute to the

development of resource calculation tools

  • Responsible for the definition and generation of metrics addressing

work volumes, compliance, quality and productivity

  • Manage the root cause analysis of issues revealed by review of

metrics

  • Responsible for the determination of actions stemming from

metrics review

  • Act as a key liaison with internal and external stakeholders

Workflow Management

  • Ensure team conformance with internal and external AE timelines

  • Oversee the daily flow of cases through Aris WF operating system.

  • Resolution of case prioritization issues

  • Co-ordinate workload balancing issues

  • Provide input to the resolution of issues relating to case

complexity

  • Manage flow of cases outside of standard workflow as needed

  • Participate in notifying AE Management of department resources

who fail to adhere to workflow business rules

  • Manage corrective actions stemming from internal or external AE

case reports review

  • Oversee AE case report inquiries received from AE management

team and LDSOs

  • Oversee AE case report inquiries received from NCA and other

Celgene stakeholders

  • Coordinate case assignment and completion to meet data lock points.

  • Coordinate the management of ICSRs received as a batch

Organized data collection

  • Support and contribute to the fulfilment of Celgene’s compliance

with organized data collection programs conducted by other

departments (i.e. Market Researches, PSP, etc) including

assisting with reviewing of project material across

Hematology/Oncology and Immunology and Inflammation franchises

Regulatory Reportability, Distribution & Submission

  • Provide leadership and oversight to ensure compliance with global,

regional and local expedited reporting requirements.

  • Support ICSR distribution process through workload allocation

and team availability

  • reasons for cases outside the internal processing as

well as regulatory timelines and implement corrective and

preventive actions as appropriate

Quality Assurance

  • Ensuring optimal quality of case reports internally (e.g. EOI quality check)

through monitoring and continuous improvement

  • Contribute to identifying root causes, action items and

action plans to correct quality issues stemming from internal or

external review

  • Facilitate communication of quality and performance findings

and cooperate with Safety Operations to address corrective and

preventative actions as needed

  • Contribute to the development of processes and tools to ensure

high quality safety data input/output in compliance with regulatory

standards

Trial Safety Support

  • Communicate with Trials Safety Team to identify and resolve SAE

reporting issues

  • Contribute to ensuring adherence of outsourced studies to dept.

standards

  • Contributes to SAE reconciliation

  • Contribute to reviewing SAE reporting plans if required

  • Supporting GDSRM International Pharmacovigilance Operations

  • Collaboration with GDSRM International Pharmacovigilance Operations

Team and maintain effective level of communication and collaboration with Affiliate Pharmacovigilance Teams

Pharmacovigilance (approved products)

  • Ensure timeliness and quality of processing of ICSRs to meet applicable data base locks for Aggregate Reports including PSURs, PBRER and DSURs across product franchises.

Compliance, Standards & Project Management

  • Participate in the creation and maintenance of Celgene Case

Management policies practices and procedures

  • Lead in the establishment and execution of Case Management projects in support of ongoing process evolution and improvement in line with internal and external drivers

Team Development & Training

  • Identify training needs of internal team as well as external

customers & feeder groups

  • Participate in the development of required training needs

Internal GDSRM International Case Management Operations Development

  • Contribute to GDSRM Case Management Goal Setting

  • Execute Performance Management for Team

  • Coordinate team participation and input in event discussion meetings

  • Conduct 1:1 Meetings with Team Members and support IDP development

  • Hire, orientate, manage, mentor, and develop staff

  • Conduct team meetings

Project Management

  • Lead or contribute to projects identified and designed to

improve ICSR management operations including impact assessment

and implementation of new legislative requirements

Continuous Improvement & Innovation

  • Participate in continuous improvement and supporting evolution and

innovation within Case Management.

  • Contribute to root cause analysis of process issues & corrective

actions, prioritize, plan improvements including ad-hoc topics

as well as those originating through Audit and regulatory

Inspection.

  • Support Training Manager to identify training needs and contribute

to facilitate them either by providing/developing educational material or participating in organization of Training

Audit and Regulatory Inspection

  • Acts as SME for both internal audits and Regulatory Authority

inspections

  • Support root cause analysis and CAPA according to completion

schedule

  • Resource for document retrieval and quality assurance of requested

documents during inspections

Preferred Role Qualifications, Experience, Knowledge & Competencies

The knowledge and skills necessary to perform the duties of this

position are typically acquired through the following combination

of education and experience or the equivalent.

Qualifications

  • Minimum of B.Sc. or the equivalent combination of relevant

education or professional experience

Experience

  • Eight (8) years pharmaceutical/biotechnology industry experience

  • Six years (6) Drug Safety experience

Knowledge

  • Excellent knowledge of pharmacovigilance regulatory

requirements (Safety and Risk management i.e. FDA, EMA and

ICH guidelines)

  • Ability to influence senior leaders in the Celgene business

without authority

  • Clinical knowledge of therapeutic area patient populations

and drug class: oncology and I&I experience preferred

  • Proficiency in technical safety systems including ARISg and medical

coding

  • Knowledge of aggregate safety data utilization

  • Good project management skills

Competencies & Behaviours

  • Team leadership, people management and development/empowerment

  • Inspires and motivates

  • Fosters team work

  • Excellent influencing and leadership skills

  • Excellent written and verbal communication skills including

presentation skills

  • Excellent interpersonal skills

  • Ability to identify and communicate issues within department

and across geographies: Matrix management

  • Ability to resolve conflict

  • Stakeholder advocacy; promote open communication and build

external relationships

  • Applies profound technical expertise

  • Effective Organisation and planning; ability to multitask and

prioritize

  • Strong attention to detail, team work and initiative

  • Solution oriented with a global mindset

  • Strong analytical skills

  • Fosters a culture of Curiosity and Continuous Learning

Qualifications

Provide leadership and support for UK based Case Management Team

Ensure effective co-ordination of AE flow through the case management workflow in coordination with Swiss based team

Ensure process conformity with applicable regulations and Celgene standards and ICSR conventions

Establishment, maintenance and monitoring of key performance indicators (KPI)

Drive Case Management process enhancement and team development

Case Management Operations Performance, Metrics & Resourcing

  • Lead goal setting, Key Performance Indicators (KPIs) development

and performance management within the GDSRM International Case

Management Operations team

  • Support central and where applicable affiliate resource calculation

and contribute resourcing strategies including hiring and supervision

of temporary contract staff

  • Liaison with HR Business Partners service providers including

resourcing for temporary staff

  • Establish team metrics to support resourcing and contribute to the

development of resource calculation tools

  • Responsible for the definition and generation of metrics addressing

work volumes, compliance, quality and productivity

  • Manage the root cause analysis of issues revealed by review of

metrics

  • Responsible for the determination of actions stemming from

metrics review

  • Act as a key liaison with internal and external stakeholders

Workflow Management

  • Ensure team conformance with internal and external AE timelines

  • Oversee the daily flow of cases through Aris WF operating system.

  • Resolution of case prioritization issues

  • Co-ordinate workload balancing issues

  • Provide input to the resolution of issues relating to case

complexity

  • Manage flow of cases outside of standard workflow as needed

  • Participate in notifying AE Management of department resources

who fail to adhere to workflow business rules

  • Manage corrective actions stemming from internal or external AE

case reports review

  • Oversee AE case report inquiries received from AE management

team and LDSOs

  • Oversee AE case report inquiries received from NCA and other

Celgene stakeholders

  • Coordinate case assignment and completion to meet data lock points.

  • Coordinate the management of ICSRs received as a batch

Organized data collection

  • Support and contribute to the fulfilment of Celgene’s compliance

with organized data collection programs conducted by other

departments (i.e. Market Researches, PSP, etc) including

assisting with reviewing of project material across

Hematology/Oncology and Immunology and Inflammation franchises

Regulatory Reportability, Distribution & Submission

  • Provide leadership and oversight to ensure compliance with global,

regional and local expedited reporting requirements.

  • Support ICSR distribution process through workload allocation

and team availability

  • reasons for cases outside the internal processing as

well as regulatory timelines and implement corrective and

preventive actions as appropriate

Quality Assurance

  • Ensuring optimal quality of case reports internally (e.g. EOI quality check)

through monitoring and continuous improvement

  • Contribute to identifying root causes, action items and

action plans to correct quality issues stemming from internal or

external review

  • Facilitate communication of quality and performance findings

and cooperate with Safety Operations to address corrective and

preventative actions as needed

  • Contribute to the development of processes and tools to ensure

high quality safety data input/output in compliance with regulatory

standards

Trial Safety Support

  • Communicate with Trials Safety Team to identify and resolve SAE

reporting issues

  • Contribute to ensuring adherence of outsourced studies to dept.

standards

  • Contributes to SAE reconciliation

  • Contribute to reviewing SAE reporting plans if required

  • Supporting GDSRM International Pharmacovigilance Operations

  • Collaboration with GDSRM International Pharmacovigilance Operations

Team and maintain effective level of communication and collaboration with Affiliate Pharmacovigilance Teams

Pharmacovigilance (approved products)

  • Ensure timeliness and quality of processing of ICSRs to meet applicable data base locks for Aggregate Reports including PSURs, PBRER and DSURs across product franchises.

Compliance, Standards & Project Management

  • Participate in the creation and maintenance of Celgene Case

Management policies practices and procedures

  • Lead in the establishment and execution of Case Management projects in support of ongoing process evolution and improvement in line with internal and external drivers

Team Development & Training

  • Identify training needs of internal team as well as external

customers & feeder groups

  • Participate in the development of required training needs

Internal GDSRM International Case Management Operations Development

  • Contribute to GDSRM Case Management Goal Setting

  • Execute Performance Management for Team

  • Coordinate team participation and input in event discussion meetings

  • Conduct 1:1 Meetings with Team Members and support IDP development

  • Hire, orientate, manage, mentor, and develop staff

  • Conduct team meetings

Project Management

  • Lead or contribute to projects identified and designed to

improve ICSR management operations including impact assessment

and implementation of new legislative requirements

Continuous Improvement & Innovation

  • Participate in continuous improvement and supporting evolution and

innovation within Case Management.

  • Contribute to root cause analysis of process issues & corrective

actions, prioritize, plan improvements including ad-hoc topics

as well as those originating through Audit and regulatory

Inspection.

  • Support Training Manager to identify training needs and contribute

to facilitate them either by providing/developing educational material or participating in organization of Training

Audit and Regulatory Inspection

  • Acts as SME for both internal audits and Regulatory Authority

inspections

  • Support root cause analysis and CAPA according to completion

schedule

  • Resource for document retrieval and quality assurance of requested

documents during inspections

Preferred Role Qualifications, Experience, Knowledge & Competencies

The knowledge and skills necessary to perform the duties of this

position are typically acquired through the following combination

of education and experience or the equivalent.

Qualifications

  • Minimum of B.Sc. or the equivalent combination of relevant

education or professional experience

Experience

  • Eight (8) years pharmaceutical/biotechnology industry experience

  • Six years (6) Drug Safety experience

Knowledge

  • Excellent knowledge of pharmacovigilance regulatory

requirements (Safety and Risk management i.e. FDA, EMA and

ICH guidelines)

  • Ability to influence senior leaders in the Celgene business

without authority

  • Clinical knowledge of therapeutic area patient populations

and drug class: oncology and I&I experience preferred

  • Proficiency in technical safety systems including ARISg and medical

coding

  • Knowledge of aggregate safety data utilization

  • Good project management skills

Competencies & Behaviours

  • Team leadership, people management and development/empowerment

  • Inspires and motivates

  • Fosters team work

  • Excellent influencing and leadership skills

  • Excellent written and verbal communication skills including

presentation skills

  • Excellent interpersonal skills

  • Ability to identify and communicate issues within department

and across geographies: Matrix management

  • Ability to resolve conflict

  • Stakeholder advocacy; promote open communication and build

external relationships

  • Applies profound technical expertise

  • Effective Organisation and planning; ability to multitask and

prioritize

  • Strong attention to detail, team work and initiative

  • Solution oriented with a global mindset

  • Strong analytical skills

  • Fosters a culture of Curiosity and Continuous Learning

Senior Manager/ Associate Director CH Case Management Operations

Location: BOUDRY, NE, CH

Job ID: 17001567