Celgene Associate Manager, Case Management Operations in Hillingdon, United Kingdom
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.
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.
Role and Responsibilities
AE CASE MANAGEMENT
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
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
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
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
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
Organisation and planning
Ability to foster Team work
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
Associate Manager, Case Management Operations
Location: Hillingdon, England, UK
Job ID: 17001684