Summary:
The incumbent is required to be an independent contributor that efficiently and effectively accomplishes drug safety tasks and deliverables with little oversight. They will be responsible for providing oversight to Drug Safety Coordinators and the case intake/data entry process. They must exhibit a solid knowledge of safety databases with regards to data entry, workflow, report generation, expedited submissions, and query activities. The incumbent should also have some clinical expertise and knowledge in order to understand postmarketed Individual Case Safety Reports (ICSRs), and extract complete and relevant medical information from source documents. Must be accomplished with regards to computer systems and experience in the management of case workflow activities.
Primary responsibilities for role:
- Assist Case Owners with ad hoc queries of the safety database to gather additional information for the purposes of analysis and inclusion into PSURs, Signal Detection Reports, and any other reports as necessary. Review and validate other individual’s queries as necessary. Knowledgeable in Business Objects as a tool for extracting data from the safety database.
- In-depth knowledge of safety databases demonstrating a proficiency in database queries and data entry conventions.
- Provide Supervision of information entered into the safety database ensuring accuracy, consistency of data, and appropriate MedDRA and WhoDrug coding.
- Reviewing worklists on a regular basis to identify any cases that have not been removed out of the worklists once finalized or have not been assigned to an individual.
- Provide oversight to Drug Safety Coordinators and ensure accuracy, completeness, and timeliness of DSC data entry and case work, providing guidance and support as necessary.
- Individual Case Safety Report (ICSR) submission manager assigning submissions and providing supervision and oversight of expedited submissions ensuring that all ICSRs are identified and submissions are timely and accurate. Implementing checks to prevent submission errors.
- E2b submissions subject matter expert with the ability to timely troubleshoot submission failures.
- Provide a check of a sampling of adverse events for accuracy, completeness and consistency at the time of submission of expedited reports and assist the DSC as needed with performing submissions.
- Ensure accurate and timely submissions of individual cases associated with PSURs (i.e. to FDA)
- Review XMLs of individual cases to be submitted as periodic reports to ensure the correct message type is displayed in the reports before submission
- Responsible for retrieving ICSR cases from EVWeb and reviewing for entry into the safety database.
- Manage and/or perform ICSR reconciliation between regulatory authorities and safety database.
- Assist the Director of Operations as necessary with input and testing of safety database during system upgrades.
Additional Responsibilities:
Prepare various types of regulatory reports and author department conventions, SOPs and WPs. Assist management with ad hoc requests. Represent Global Pharmacovigilance department and deliver presentations at project and interdepartmental meetings when necessary. Communicate issues and problems to project team members and Global Pharmacovigilance Director in a timely manner. Provide process improvement suggestions. Support the GT Quality Assurance Department by providing AE data for APRs and YBPRs. Assume management responsibilities for the DSCs. Maintain continuous knowledge expertise in local and global requirements for safety reporting. Assist the Drug Safety Coordinators with data entry of adverse event cases, submissions, importing of e2b casess, and case statuse log management and booking in cases into the database when volumne is high or other situations as determined by the Director of Operations.
Knowledge, Skills, & Abilities:
- Must demonstrate good project management skills and be responsible for prioritizing individual work product and ensuring timely completion of tasks. 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.
Requirements:
- BS in health science field, Pharmacy, CRA, biomedical sciences with 2 years of experience OR MS in health science field, Pharmacy, CRA, biomedical sciences with 1 year of experience
- Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Occupational Demands:
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, 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.
