Drug Safety Scientist

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Drug Safety Scientist

The Drug and Safety Scientist is required to multi-task and manage multiple projects relating to adverse event intake and safety data base management and meet project timelines. The incumbent must also exercise clinical expertise and judgement in order to extract complete and relevant adverse event and medical information from adverse event reports; will be responsible for adverse event entry and management into the safety database; must be able to help identify safety trends vital to the organization and have excellent knowledge of safety databases and safety systems.

Primary responsibilities for role:
Determining country reporting and ensuring local country compliance with respect to ICSRs
Provide management, oversight, and guidance to the Drug Safety Coordinators (DSCs) who manage the safety inbox and perform the data enter of cases into the safety database
Willingness to assist other and perform DSC tasks when necessary to ensure ICSRs are entered into the safety database
Assign cases, tasks and projects as needed to DSCs
Author SOPs and Work Instructions, managing the SOPs for publishing
Strong safety database skills to extract data accurately and quickly and knowledgeable about the generation of safety reports as needed to support GPV activities.
Ability to triage cases and determine required action. Assign priority to incoming events and classify them according to regulatory reporting criteria.
Evaluate cases for seriousness, relatedness, and expectedness to ensure correct database entry
Review adverse events for accuracy, integrity, and consistency. Review relevant source documents for consistency and verification of adverse event data
Perform Quality Control (QC) on information entered into safety database and ensure accuracy of coding.
Prepare regulatory reports such as CIOMS I, MedWatch, E2b, etc. for submission to regulatory agencies
Represent Global Pharmacovigilance (GPV) department and deliver presentations at department and interdepartmental meetings when necessary.
Communicate issues and problems to project team members and GPV Director in a timely manner.
Provide process improvement suggestions.
Ability to successfully manage and train other employees and provide constructive feedback as necessary to ensure satisfactory deliverables from the team and encourage team cohesiveness.
Knowledge and experience with Excel and PowerPoint and be able to create pivot tables and slide presentations incorporating graphs and charts.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Requirements:Education:
BS in health science field, RN, PharmD, CRA or equivalent is strongly preferred.

Experience:
2-4 years of relevant experience is required. At least 1 years of direct experience with adverse event reporting and safety database management is required.

Must have in depth knowledge of medical terminology; be willing to assume a high level of responsibility assuring proper reporting of adverse events within the timelines. Must be a team player; possess excellent interpersonal skills, telephone/communication skills, flexibility, organizational skills, and ability to prioritize. Must be detail oriented and be willing to work in a hectic paced environment with time-sensitive materials. Must provide back-up for other members with similar responsibilities based on relative workloads, to assure all team members work within reporting timelines. Computer literacy required. Excellent analytical skills required, including the ability to comprehend and integrate scientific data from a variety of sources.

Occupational Demands:
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

EEO Minorities/Females/Disability/Veterans

Location: NORTH AMERICA : USA : NC-Clayton : USNC0002 - Clayton

Learn more about Grifols