BrightOwl Loader Loading

Senior Manager/ Associate Director CH Case Management Operations - Switzerland  

Company managed [?] Still accepting applications

Posted on : 12 August 2017

Project Description

Req #: 17001567
Location: BOUDRY, NE CH
Job Category: Medical
Work Location: Boudry, Switzerland Route de Perreux 1 Boudry 2017
Organization: Celgene R&D Sarl
Schedule: Full-time
Shift: Day Job
Employee Status: Regular
Job Type: Experienced
Job Level: Manager
Travel: Yes, 10 % of the Time

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