Celgene Associate Manager Case Management Ops – GDSRM Int. Switzerland in BOUDRY, NebraskaSwitzerland

Description

Purpose:

  • To manage safety data within Celgene’s central safety database in

support of Pharmacovigilance and Trials Safety analysis and reporting

  • To manage the development of Case Management Staff

  • To monitor and coordinate logistical elements of safety data

assessments

  • To ensure process conformity with defined standards through aligned

staff work practices & KPIs for Compliance, Productivity & Quality

  • Support Case Management Operations ICSR Quality Assurance Activities

  • To contribute to regulatory compliance through effective management of

business processes developments

Context and Responsibilities:

The Associate Manager, GDSRM International Case Management Operations is:

  • A regional role based, in Stockley Park UK or Boudry CH

Reports (at a minimum) to:

  • Case Management Operations Associate Director/Snr Manager

Responsible for:

  • Management and development of Case Management Staff

  • Ensuring that individual Adverse Event Case Reports are evaluated,

investigated and accurately processed onto the Global Drug Safety Database

  • Contributing/Supporting coordination of workflow management for ICSRs

  • Ensuring quality and accuracy of ICSR content and format in support of ICSR

and Periodic Report creation and submission

  • Supporting ICSR Quality Review and CAPA

  • Ensuring reporting and submission of ICSRs to NCAs in adherence with regulatory

reporting timelines

  • Ensuring a singular approach to case management across GDSRM International

Case Management Operations

  • Maintaining productivity and quality metrics

Key Activities:

AE CASE MANAGEMENT

Process

  • Facilitate and execute issue resolution surrounding complex AE cases

  • Escalate potential safety signals from case management staff to appropriate medical review, pharmacovigilance and risk management channels

  • Execute case load assignments and distribution among case management

staff

  • Support medical review of AE cases, specifically, identify corrections and

make updates in ARISg as required

  • Contribute to establishment of or updates to conventions and templates

  • Create work aids and tools to facilitate case management process

  • Contribute to distribution and submission of priority cases as needed

Workflow Management

  • Support with AE Management to address workload balancing issues across

CH and UK and within specific steps of the case management workflow

  • Support workflow management related tasks as required

  • Manage the resources for case processing within the assigned roles to ensure

adherence to regulatory compliance guidelines

  • Manage resources to balance workload issues

  • Support Workflow Managers by managing AE case report inquires received

from AE management team and LDSOs

Performance Metrics and ICSR Quality Assurance

  • Responsible for the definition and generation of metrics addressing

productivity and quality performance including where appropriate

the random sampling of ICSRs processed by GDSRM International Case

Management Operation Team members and

Non Celgene Contractors if applicable.

  • Contribute to the identification of ICSR quality topics and support

development of plans to correct quality issues and implementation

of CAPAs for ICSRs processed by Celgene and business partners as

required.

  • Facilitate communication of QA findings across direct reports

Continuous Improvement

  • Identify and coordinate continuous improvement initiatives

  • Review already analyzed issues, priorities and plan and implement

improvements

  • Root cause analysis of process issues and corrective actions

COMPLIANCE, STANDARDS, TRAINING & PROJECT MANAGEMENT

  • Support the evaluation of current processes and assessment of

alignment with regulatory expectations, guidelines, mandates

  • Collaborate with Training function to identify training needs, plan trainings and

support the development of subject matter experts

  • Support of global regulatory inspections and audits

INTERNAL Global SAFETY DEPARTMENT DEVELOPMENT

  • Create Policies, guidelines, SOPs and WPs

Manage & Develop Staff

  • Contribute to the hiring, orientation, management, mentoring, and

development of staff

  • Advocate organizational changes necessary for developing and retaining top

talent

Decision Making Authority

  • Day-to-day staff management and in-process decisions

  • Adverse Event case reports availability within defined process and timelines

  • Staff and Contract Staff recruitment

  • Staffing and management decision

  • Resource management

  • Oversight of all decisions made by direct reports

  • Resolution of case workflow issues

Outputs:

  • Correct adverse event case report data, including narratives within the central

safety database

  • Consistent process practices

  • Metrics for productivity and quality

  • SOPs, WPs and templates

  • Work aids and tools relevant to function

  • ICSR Random Sample Review outputs

  • EIP and IDP documentation for direct reports

  • Input into SAE management plans, conventions

Qualifications

Qualifications

Minimum of B.S. or the equivalent combination of relevant education or professional experience

Experience

  • Four (4) years relevant clinical experience

  • Two (2) years pharmaceutical/biotechnology industry experience

  • Pharmacovigilance & Case Management experience

  • Supervisory, People Management experience

Knowledge

  • Understanding of global regulatory requirements for pharmacovigilance

  • Clinical knowledge of therapeutic area patient populations and drug class

  • Proficiency in technical safety systems including ARISg and medical coding

  • Understand utilization of aggregate safety data

  • Computer and database skills

Competencies

  • Organisation and planning

  • Ability to foster Team work

  • Team Leadership

  • People management and development

  • Ability to Inspire and Motivate

  • Managing difficult situations and conflict resolution

  • Attention to detail and initiative

  • Proficient communication skills

  • Data management and analytical skills

  • Time management

  • Solution oriented

  • Flexibility

  • Matrix management

Associate Manager Case Management Ops – GDSRM Int. Switzerland

Location: BOUDRY, NE, CH

Job ID: 17001694