Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.About the RoleThe Global Risk Management Plan Manager provides support to the medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely manner. Initiates the tracking of commitments and liaises with relevant functions that maintain and monitor the commitments.Support the Global Product Safety Leader (GPSL) and the designated medical writer for the timely preparation, development and finalization of high quality and regulatory compliant safety Risk Management Plans (RMP).Support the GPSL/GPT to resolve issues as they arise regarding the RMP strategy, RMP preparation, RMP implementation and RMP overall process.Guide the GPSL and key authors to ensure that commitments are appropriately worded and reviewed by all relevant line functions and comments incorporated into final document.Coordinate activities from the different line units to ensure all documents required to support the RMP main document are included in the RMP annexes and available in the Document Management System according to Novartis processes.Manage all logistical aspects related to the timely development of the safety RMP annexes and works with authors of the different line functions to ensure RMP annexes content meets Novartis and Health Authorities (HA) requirements.Support the Safety Lead in updating the RMP according to HA requirements and ensures they are aligned with Periodic Safety Update Report (PSUR)/ Periodic Benefit Risk Evaluation Report (PBRER).Review the RMP to ensure consistency and regulatory compliance of RMP sections and annexes.Track HA feedback and assessment on RMP and ensures HA requirements are implemented as required (e.g. in individual RMP, in global RMP template).Timely submission and delivery of high quality RMPs to Health Authorities.RMP document and annexes are fully compliant with Novartis and Health Authorities technical and format requirement.All documents required to support the RMP main document are included in the RMP annexes and available in the Document Management System according to Novartis processes.Distribution of RMP CoSTA commitments to affiliates and HQ GPT is performed within 15 working days of Health Authority approval.Database of Health Authorities feedback on RMP is kept up to date.Experience/Professional requirement:At least 5 years in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs.Proven ability to work with large cross-functional teams in complex projects. Has demonstrated teamwork and effective communication skills. Works effectively and is able to establish relationships with other line functions.Knowledge in worldwide regulatory requirements for drug registration (scientific and technical aspects) and clinical drug development.Proven ability to interpret, discuss efficacy and safety data relating to multiple therapeutic areas.Solid Medical/Scientific writing and verbal skills.Languages: Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable.Education:(minimum/desirable): Scientific Degree required. Advanced degree (Masters, PharmD or PhD) desirable.Commitment to Diversity & InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Accessibility and accommodation:Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to ****** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
#J-18808-Ljbffr
