Director Of Security Jobs in Connecticut

Job Title: Drug Surveillance Manager Company: Boehringer Ingelheim GmbH Location: Ridgefield, CT Description: Boehringer Ingelheim is currently seeking a talented and innovative Drug Surveillance Manager to join our /Medicine & DRA-Drug Surveillance and Information department located at our US headquarters in Ridgefield, CT. As a Drug Surveillance Manager, you will be responsible for ensuring that adverse events are processed, analyzed and reported according to Corporate SOP's, Local working instructions and local regulatory requirements. Responsible for distribution and retrieval of data to internal and external customers as needed for analysis and compliance with regulations. Serve as point of contact with clinical team in areas of adverse event process. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Responsibilities: * Ensures the processing of adverse event reports in a timely fashion as specified by Federal Regulations, Local Working Instructions and Corporate SOP's. This involves the management of daily workload for Data Entry and Quality Control. This includes analysis and classification of reports, coding of data, clarification of questions with appropriate personnel and queries.* Assists in developing and/or implements customized training programs regarding the application of Corporate SOP's and Local Working Instructions to both internal and external personnel involved with the processing of safety information. Acts as the safety representative for project teams which includes reviewing/approving safety sections of clinical trial documents, reconciliation activities and any other operational safety issues. Actively participates in reconciliation activities regarding the safety database.* Oversees and/or directly generates reviews and signs off on aggregate reports (i.e. NDA Periodic and IND Annual) to FDA, ad hoc and validated custom reports for use in analysis or reporting to FDA. * Acts as operational safety contact for receipt of cases and queries and manages reconciliation activities with clinical teams and licensing partners.* Act as operational safety contact for Validation members and Medical IT to address system issues. Participates in user testing, creation of user requirements and Quality Control or validation of such reports.