The Intake and Reporting Manager is responsible for performing Individual Case Safety Report (ICSR) intake and reporting activities, including but not limited to Individual Case Safety Report (ICSR) receipt, distribution and other ICSR workflow tasks as required. The Intake and Reporting Manager works with a high degree of independence and is proficient at troubleshooting problems to create and execute improved procedures, and to ensure compliance with applicable regulatory requirements. This individual ensures that all work performed is in accordance with relevant regulatory guidelines. By virtue of their experience, the Intake and Reporting Manager is expected to provide guidance and leadership for the ICSR Intake and Reporting Team and complete work in a resourceful, self-sufficient manner.
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
Sound ability to communicate effectively in a matrix environment
Ability to multi-task
Solid written and oral communication skills
Sound attention to detail
Strong sense of responsibility and an ability to work autonomously, as well as act as a strong team player
Displays ability to understand established procedures and communicate those procedures to others
Manages the day to day operations of the ICSR Intake and Reporting Team
Oversees monthly team metrics and ensures targets are met
Manages and trains Intake and Reporting staff
Performs and oversees receipt and timely book-in of all safety information including but not limited to, Adverse Events (AEs), Serious Adverse Events (SAEs), and pregnancy reports from all sources
Performs and oversees the timely and complete reconciliation with Business Partners and/or Vendors
Ensures that all Standard Operating Procedures (SOPs) and Work Instructions (WIs) are followed
Work in close collaboration with cross-functional stakeholders (e.g., Global Medical Information, CMC and Patient Safety QA) to ensure process alignment and compliance
Assists in the training and development of other staff members in key processes and procedures
May conduct presentations of ICSR initiatives and projects
Provides input on effectiveness of the safety management system and when applicable, provide suggestions for improvement of ICSR intake and reporting efficiency
Reviews and may be responsible for authoring SOPs and WIs, with minimal supervision
Helps to identify key departmental needs and provides constructive input on solutions
May assist with PV Agreements and manage relationships with Vendors/Business Partners as assigned
Performs other duties as assigned
B.S. (or equivalent degree) and 4 5 years of relevant work experience, or
PharmD, M.S.N (or equivalent degree) and 3 5 years of relevant work experience
Excellent project management skills with the ability to align internal and external resources.
Strong sense of responsibility and an ability to work autonomously, as well as act as a strong team player.
Ability to react constructively in a high-energy and fast paced environment.
Outstanding interpersonal and communication skills including verbal/written and presentation skills.
Successful track record of mentoring (or managing) staff and projects
Ability to effectively represent ICSR on multi-disciplinary teams; ability to evaluate and analyze procedural gaps.
Experience with operational aspects of Clinical trials and post-marketing ICSR reporting required.
Experience with managing vendors, partners and CROs highly preferred.
Solid understanding of drug development process and drug safety regulatory requirements, including knowledge of safety reporting in clinical trials, post-marketing surveillance, case processing and reporting to Regulatory Authorities worldwide.