Safety Scientist

Brief Description:

This position is primarily responsible for supporting all operational functions within the Global Case Processing unit including, but not limited to, client interface and deliverables, safety report case processing and reporting; global and local literature review, assisting with project start-up; training and contributing to the development and maintenance of departmental standard operating procedures (SOPs) and guidelines.

Safety Scientist

Specific Job Duties:

·        Assist with the preparation of relevant project specific plans and procedures and other plans linked to case processing and literature activities as required

·        Ensure all processes as described in relevant procedural documents are operational

·        Responsible for processing and evaluating (i.e narrative writing, seriousness rating, causality and expectedness assessment) safety reports originating from clinical studies, literature and the post marketing experience for client products.

·        Responsible for the timely completion of safety reports for distribution to Health Authorities, clients and client’s partners.

·        Responsible for the timely identification of Safety Reports and/or relevant safety information during the monitoring of the literature

·        Responsible for Quality Control of Case Processing and Literature Review deliverables

·        Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: safety reports, aggregate data, line listings

·        Ensure the timely and accurate completion of case processing due diligence activities

·        Ensure the timely and accurate completion of reconciliation activities

·        Assist in the reconciliation of clinical and safety databases

·        Prepare and follow through to completion the Safety Database requests (case deactivation, Output Request, Change Control and User Access Request Forms as appropriate) for UBC PV management review and approval

·        Assist, in conjunction with the Argus team and UBC PV management, in User Acceptance Testing (UAT), including, but not limited to, coordination, generation, and execution of test scripts.

·        Liaise with both internal and external clients

·        Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations.

·        Alert UBC PV Management when activities fall outside contracted tasks in Scope of Work (SOW) or applicable procedural documents

·        Provide and assist with appropriate documentation of non-compliance with regulatory requirements  and / or applicable procedures in Safety Incident Reports (SIRs), Problem Notification Forms and Corrective and Preventive Actions (CAPA) as required

·        Support in client audits and regulatory inspections from a pharmacovigilance operations standpoint

·        Other duties as assigned by UBC PV management

Requirements:

·        Registered Nurse, Pharmacist, or other degree in a science or health-related field

·        Good knowledge of global and local pharmacovigilance (PV) regulations and legislation, both pre-and post-marketing required.

·        Minimum of 1 year of experience in a pharmaceutical company or a service provider (e.g. CRO) with case processing responsibilities

·        PV processing experience should include drugs. Experience with safety surveillance of vaccines, biologics and medical devices a plus but not required Proficient with case processing including use of coding dictionaries, case narratives preferably within Argus. Experience with other PV databases (e.g. ARISg) a plus, but not required. Experience in expedited reporting a plus, but not required

·        Proficient with computer programs (Microsoft Outlook, Word, PowerPoint, Excel)

·        Good communication, interpersonal interaction, and organizational skills are essential

·        Ability to manage multiple client projects simultaneously with good time management skills

·        Fluent in English, additional language fluency a plus, but not required

ABOUT UBC

United BioSource Corporation (UBC) is the leading provider of integrated pharmaceutical support services that optimize global product safety, brand loyalty and patient access on behalf of our manufacturer clients.

UBC’s services include Clinical Development & Late Stage Research, Risk Management & Pharmacovigilance, Reimbursement & Patient Assistance, Nursing & Adherence and Product Access & Channel Management.  UBC works hand-in-hand with Accredo and CuraScript SD to contract with manufacturers for specialty pharmacy and distribution services.

ABOUT EXPRESS SCRIPTS

Advance your career with the company that makes it easier for people to choose better health. Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes. Join the company that Fortune magazine ranked as one of the "Most Admired Companies" in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services. We offer a highly competitive base salary and a comprehensive benefits program, including medical, prescription drug, dental, vision, 401(k) with company match, life insurance, paid time off, tuition assistance and an employee stock purchase plan.

Express Scripts is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, national origin, age, veteran status, disability, or any other protected class. Applicants must be able to pass a drug test and background investigation. Express Scripts is a VEVRAA Federal Contractor.