Summary: Responsible for participating in adverse event case management, to include assisting Sr Safety Scientist and Program Manager in client related Adverse Event Management activities, processing cases under the single case ownership models as to remain current with the activity, and providing support to other Safety Scientist in terms of the clinical management of the case and its prioritization.
The Safety Scientist supports clients on assigned team or teams, depending upon volume and case complexity, and resolves issues and works with the Project Physicians and PV Manager to consistently assess case quality and establish plans and actions for improvements.
Essential Duties and Responsibilities include the following:
Assist with the preparation of project plans as required
Alert Program Manager when activities fall outside SOW
Process and evaluate AE reports according to the customers standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment
Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings
Preparation of training materials specific to safety, participate and/or lead training sessions.
Assist in the reconciliation of clinical and safety databases.
Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment
Perform literature review for identification of case reports and other relevant safety information
Review/Quality Check (QC) of source documents, coding, data entry, report generation and distribution
Assist in evaluation and validation of systems to support safety.
Other duties as assigned by management.
Perform triage of cases prior to case processing.
Mentor, train, and update of new and existing staff on clients.
Inform appropriate Telerx staff of delayed, missing or incomplete items; ensure follow-up and completion of all transactions are performed in a timely manner.
Utilize Medical Review staff of issues to assure patient safety, manage client risk, understand and manage salient clinical/medical issues, adjudicate and reconcile conflicting or difficult clinical issues.
Minimize Telerx risk and collaborate with Quality Standards to assure regulatory compliance.
Communicate key issues and milestones, and facilitate Telerx management of client expectations.
Partner in new client implementations and client meetings and preparation of meeting agendas and minutes, as required.
Ensure that all internal and client-specific activities are performed in compliance with appropriate Regulatory requirements.
Participate in quality assessment reviews and audits.
Education and/or Experience: Safety Scientist must be a healthcare professionals (RN/LPN preferred), or possess equivalent PV experience. Experience from bio-pharmaceutical organizations, drug safety or other service providers is preferred and may be required based upon client demands. Clinical background with experience in various therapeutic areas with more demanding clinical skills may be required based upon client specific needs. The ability to handle high case volume and complex cases, as necessary; PV experience, includes safety system experience, case processing, ability to interface with global safety teams/other teams formed to assess the continuing safety profile for the compound or product; Clinical Trial and post marketing experience is preferred and may be required to meet client needs
Language Skills: Excellent oral communication skills and writing skills. Ability to read and interpret documents such as safety rules, standard operating procedures (SOPs) or other job aids, to write routine correspondence, to speak effectively and informatively, and respond to questions from customers, clients or associates of an organization, over the phone or in-person.
Reasoning Ability: Excellent analytical ability and problem solving skills, including ability to trouble shoot issues and propose solutions. Ability to apply common sense understanding to carry out instructions provided in written, oral or diagram form and to deal with problems involving several concrete variables in standardized situations.
Computer /Technical Skills: Strong MS Excel, Word, and PowerPoint skills. Computer literate; previous safety database experience highly desirable. ARGUS or Arisg experience a plus.
Other Skills and Abilities: This position may require participation in and possible travel to training sessions, completing self-study, certification and call monitoring; ability to manage difficult, irate or emotional customers while maintaining composure; ability to multi-task; demonstrated ability to manage time, establish and maintain productive working relationships with all levels within the organization; strong data integrity and attention to detail.
Certificates, Licenses, Registrations: This position requires completion and certification of all program-related training. Current healthcare license may be required based upon program requirements.
C3i Solutions is a world-wide business process outsourcer specializing in the multi-channel engagement of consumers, patients, healthcare professionals and enterprise personnel via a network of global contact centers.
Our unique customer-centric approach has made C3i Solutions the partner of choice for some of the world’s most trusted brands for more than 30 years. C3i Solutions provides unpa...ralleled 24/7 support to customers in over 100 countries speaking 30 different languages.
With strategic focus on innovation and regulatory compliance, C3i Solutions handles more than 35 million interactions per year, helping our clients build and protect their brands while maximizing productivity and cost efficiencies. More than 90 percent of the company’s clients are FDA-regulated.