Celgene Associate Manager, Case Management Operations in Hillingdon, United Kingdom

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.

Summary

  • To manage safety data within Celgene‚Äôs 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.

Role and Responsibilities

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

Qualifications

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

  • Relevant clinical and 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

*MONEU

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Associate Manager, Case Management Operations

Location: Hillingdon, England, UK

Job ID: 17001684