Kerstin Fleischer

WORK HISTORY

EDUCATION

SKILLS

ABOUT KERSTIN FLEISCHER

Provide budgetary, operational, and personnel leadership for a team of Pharmacovigilance staff. Oversee implementation of Chiltern Pharmacovigilance procedures. Ensure that reported adverse events meet applicable regulatory timelines.Key areas of Responsibility: · Responsible for the selection, training, development, and performance management for a team of Pharmacovigilance staff· Assign responsibilities to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business· Support Business Development efforts with new and revised projects. Interact independently with Sponsors not directly involved in their projects and to assist in wider departmental tasks. Represent the department at face to face meetings.· Oversee development of project-specific Pharmacovigilance budgets and proposals· Ensure Safety Management Plans and the safety database are adequately prepared for projects· Perform the following, in conjunction with the sponsor: advise on pharmacovigilance aspects of a study; write or advise on pharmacovigilance sections for protocols and other documents· Partner with sponsor or Chiltern Medical team to address issues arising from adverse events reported to Pharmacovigilance· Ensure that they, and/ or their respective teams, provide the counsel and subject matter expertise to other Chiltern departments· Involved in process development, SOP generation and SOP updates· Involved in implementation of Argus 8 incl. workflow development, SOP update, development of supporting documents (e.g. Data Entry Manual)· Development and providing training on Argus 8· Perform other duties as required by the Department