Celgene Associate Director, UK 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.
Based at Celgene Europe Limited in Stockley Park, UK reporting to the Head of Case Management Operations Global Drug Safety and Risk Management (GDSRM) International, this individual is responsible for providing leadership and oversight for the UK based team.
Responsibility also extends to the effective co-ordination and execution of Adverse Event processing through the GDSRM International case management workflow ensuring process conformity with regulatory requirements including expedited reporting timelines, applicable regulations, standards and Celgene policies, practices and procedures.
This individual is a subject matter expert in the area of pharmacovigilance and contributes actively in the maintenance and evolution of Celgene’s Pharmacovigilance System as it relates to the management of Safety Data in particular the management and processing of Individual Case Safety Reports which contribute to the continuous benefit-risk assessment of Celgene products throughout their life-cycle.
This individual will ensure through close coordination with their Case Management Counterparts within the GDSRM International Team in Boudry Switzerland and US based GDSRM Case Management team, a seamless case processing continuum in support of business continuity and maintenance of exquisite quality and compliance.
Role and Responsibilities
Acting as site lead for UK based Case Management teams.
Provide leadership in execution of adverse event case management activities performed by team in the UK in coordination with GDSRM International team based in Boudry, Switzerland.
Co-ordination of staff deployment and development to ensure effective and efficient AE management and prioritization.
Line Management - Responsible for UK based Safety Data Management.
Lead workload balancing and capacity issues for Safety Data Management.
Responsible for execution of Work Flow Management and Safety Data Management to address case processing inquiries received from the Central, Regional and Affiliate Pharmacovigilance Teams and other internal/external stakeholders.
Lead and coordinate root causes analysis and identify preventive, corrective action required for ICSR management issues.
Manage and oversee the triage, data entry, assessment, due diligence, distribution & submission activities performed in the UK.
Case Management Operations Performance, Metrics & Resourcing
Contribute to 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
Establish team metrics to support resourcing and contribute to the development of resource calculation tools
Ensure conformance with internal and external AE timelines
Co-ordinate 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
Organised data collection
- Support and contribute to the fulfilment of Celgene’s compliance with organised data collection programs conducted by other departments (i.e. Market Researches, PSP, etc) including assisting with reviewing of project material across Haematology/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
Investigate reasons for cases outside the internal processing as well as regulatory timelines and implement corrective and preventive actions as appropriate
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.
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
- Lead or contribute to projects identified and designed to improve ICSR management operations
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
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
Minimum of B.Sc. level University degree or the equivalent combination of relevant education or professional experience
Solid Drug Safety experience gained from a Pharmaceutical and / or Biotechnology company
Proven track record of people management
Skills and Knowledge required
Excellent knowledge of pharmacovigilance regulatory requirements (Safety and Risk management i.e. FDA, EMA and ICH guidelines)
Excellent influencing and leadership skills
Excellent practical and technical knowledge of ICSRs management
Excellent interpersonal and presentational skills to represent the GDSRM International team with impact and influence
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
Good project management skills
Associate Director, UK Case Management Operations
Location: Hillingdon, England, UK
Job ID: 17001336