Apply Now    

Senior Director, Case Management

Req #: 16000625
Location: Berkeley Heights, NJ US
Job Category: Medical
Work Location: Berkeley Heights, NJ300 300 Connell Dr Suite 6000 Berkeley Heights 07922
Organization: Celgene Corporation
Schedule: Full-time
Shift: Day Job
Employee Status: Regular
Job Type: Standard
Job Level: Director
Travel: No


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 ensure Celgene sustains excellent regulatory compliance and credibility

·         To ensure excellence in safety report evaluation and management supporting safety   surveillance of development & marketed products

·         To ensure effective and productive business partner collaborations, and to assure excellent corporate risk management

·         To manage ICSR report evaluation and management production staff

To ensure the production of quality reports that meet global regulatory requirements and standards

Key Activities


SAE/AE Case Processing

·         Ensure appropriate medical content of SAE and PMAE reports permitting case evaluation and utilization in aggregate analysis

·         Oversee development and systematic improvement of SAE and PMAE data collection methods

·         Oversee coding and convention standards within the database


·         Ensure corporate safety database content is comprehensive and analysis ready

·         Support the activities of pharmacovigilance MDs and Epi personnel, modifying the database output where required

Trial Support

·         Support Trials Safety Surveillance & Logisitics groups in pursuit of SAE acquisition and availability for analysis and reporting

·         Ensure appropriate representation of SAE reports for inclusion in CSRs, ISS, DSURs, update and periodic reports

·         Operationalize process agreements and work distributions with Clinical and Medical Affairs, CROs, and other external agents

·         Ensure effective liaison with Trials safety managers in the reconciliation of SAEs across Trials and safety databases

Commercialization support and liaison to other functions

·         Ensure that management flow and distribution of safety information is globally consistent and reporting timelines are maintained as required by regulatory agencies

·         Participate in the development of pharmacovigilance agreements, contracts and MOU’s with licensees, commercial agents and business partners

·         Develop outsourcing/vendor selection strategies and relationships

·         Direct and ensure standardization of safety requirements and quality oversight both internally and externally on a global scale

·         Contribute to the selection and evaluation of contractors/consultants

·         Establish and maintain international collaboration, foster effective interactions and communications with local, regional and global Celgene staff and Global Regulatory Authorities

·         Ensure effective liaison with Customer Care, Patient Support, Medical Information, Product Quality, Risk Intervention, Global Compliance, Marketing Research, Medical Affairs, Clinical Operations and Registry departments both locally and globally

Internal Global Drug Safety and Risk Management

·         Strategic leadership, definition and accountability for Celgene Global individual case report evaluation and management

·         Ensure Celgene sustains excellent global regulatory safety requirement compliance

·         Create resource requirement projections, development of capacity model and manage resources

·         Ensure creation and ongoing development of ICSR group process metrics and compliance metrics

·         Create, sign off and maintain policies, guidelines, SOPs and WPs for ICSR processing

·         Hire, manage, mentor, orientate, and develop ICSR

·         Support implementation of HR processes and initiatives

·         Clarify and codify boundaries, support and handoffs with GDSRM

·         Support internal and external auditing of GDSRM

·         Support the development and realization of the GDSRM department’s vision and long range plan

·         Support development and execution of global safety staff education and training

·         Establish and maintain supportive relationships with Celgene affiliates and business partners

·         Budget formulation and management for Case Mgmt and Evaluation department

·         Ensure adherence/compliance and adapt processes for ICSR submission documents  as legislation changes dictate

·         Direct Celgene Case Mgmt and Operations staff


Compliance, Standards, & Project Management

·         Facilitate and ensure the evaluation of current processes and assess alignment with regulatory expectations, guidelines and mandates

·         Ensure inspection readiness in functional area of case management

·         Ensure compliance metrics for functional areas meet industry benchmark standards at a minimum


·         Issues management

·         Expedited ICSRs submissions

·         Regulatory Compliance metrics

·         Productivity and Cost Effectiveness metrics

·         MAP/MIP documentation

·         SOPs/WPs/Guidelines/Conventions

·         Consistent safety data across trials and safety databases

·         Safety data output for strategic use

·         Potential and established signal recognition assessment

·         Quality Metrics for ICSRs

Context &Responsibilities:

·         Global role based in Berkeley Heights, NJ


Reports to:

·          Corp Vice President Global Drug Safety and Risk Management


Responsible for:

·         Ensuring global regulatory compliance

·         Leading change initiatives within the department and in interactions with other departments

·         Effective acquisition, assessment, investigation & computerization of safety reports

·         Reporting compliance, standards, training and inspection readiness across the case management and operations group

·         Coordination with Celgene International groups on reporting standards and processes

·         Strategizing, directing and evaluating ICSR process flow, metrics and process improvement for clinical trials and post marketing reports

·         Capacity/Demand management including contracting and consulting

·         Ensuring appropriate procedures, guidelines and training for all Celgene staff relating to effective safety report standards as pertains to ICSRs

·         Ensuring proactive analysis of safety information

·         Recruiting, hiring, retaining and developing Case Mgmt & Operations staff




Healthcare professional with Bachelors degree or higher and proven operations excellence


· Ten (10) years relevant pharmaceutical/biotechnology industry experience, preferably in  drug safety and pharmacovigilance

· Ten (10) years relevant clinical acute care setting experience (post degree)

· Ten (10) years management experience

· Regulatory inspections experience


· Mastery of global regulatory requirements for pharmacovigilance

· Clinical knowledge of all therapeutic area patient populations and drug classes

· Proficiency in technical safety systems and medical coding

· Knowledge of signal recognition, statistical techniques and trials safety methods and outputs

· Mastery of safety report processing operations and systems

· Issues management

· Knowledge of development of global labeling documents

· Knowledge of establishment of the benefit risk profile for products

· Subject matter expert for regulatory inspections


· Departmental Leadership

· Strategic thinking

· Scientific/Technical Leadership

· International Networking

· Decision Making Skills

· Communication Skills

· Presentation Skills

· Writing Skills

· Problem Solving

· Information Analysis

· Effective team working

· Negotiating

Interdisciplinary Leader

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. 

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.


Apply Now    

Not ready to apply?

Join Our Talent Network

About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

Global Network

world map