Drug Safety Associate I
Posted DateNovember 26, 2019
Provide broad range of drug safety operations support, including recordkeeping, processing, and reporting of serious adverse events (SAE) from all clinical trials.
- Responsible for monitoring inbound mailboxes, fax machines, and/or other inbound systems for adverse event cases, and forwarding to the appropriate DSP manager for triage.
- Perform intake of adverse events, data entry of initial and follow-up for adverse event reports, including coding verbatim AE terms, medical history, laboratory data, and drugs using MedDRA and WHO Drug Dictionaries.
- Process post-marketing adverse event reports including writing safety narratives, entering data into the safety database, and identifying queries under the direction of DSP associates and case managers.
- Tracking and submission of reports to collaborative partners
- Search VAERS CDC Wonder to identify post-marketing reports
- Responsible for collaborating with Information Technology in managing tickets related to the safety database including the initiation, routing, approval, and filing of change requests
- Perform, track, and report on the status of routine follow-up/queries on adverse event reports (postmarketing and clinical)
- Must be able to recognize and understand when to triage or consult with supervisor when requiring guidance.
- Plan and maintain coordinated processes between Drug Safety and PVG and other internal and/or external groups (eg, CRO) for timely and accurate transfer of files/data as required.
- Assist in reconciliation activities, including review of SAE files source data.
- Maintain holiday schedules to ensure all SAEs are handled in accordance with safety regulations and department procedures, and communicate to internal/external groups as necessary during scheduled holidays and non-business hours.
- Assist in the preparation of aggregate data for safety review sessions.
- Create and/or maintain multiple tracking spreadsheets, and routinely provide compliance metrics and trending reports for management and study teams.
- Assist in supporting audits and inspections; create and maintain audit-ready files, including training files.
- Maintain both electronic and paper files.
- Responsible for scanning and uploading adverse event case information to our safety systems, monitoring electronic mailboxes for adverse event reports, responding to queries and follow-up local reference numbers when required.
- Responsible for ensuring that study relevant safety documents are filed in the study specific eTMF.
- Conduct monthly literature search
- Perform tracking and reconciliation of incoming adverse event reports, investigator letter distribution, regulatory submissions, etc.
- Participate/contribute in the development of departmental SOPs, work instructions, and other training materials.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Perform other operational tasks in support of Drug Safety & Pharmacovigilance Operations as required by management.
- Other duties as assigned.
- BS in biological/life sciences and two years related experience. An advanced health degree such as PharmD, NP or health care professional with relevant clinical experience may substitute for years of related experience.
- An understanding of both domestic (FDA) and international (ICH) regulatory requirements and drug safety reporting procedures.
- Must be able to maintain confidentiality (especially on patient records), quality, and accuracy.
- Strong communication skills are required, including appropriate email etiquette.
- Experience with medical terminology.
- Demonstrated attention to detail, follow-through, and initiative.
- Must be able to work with minimal supervision, have strong team orientation, and be collaborative.
- Familiar with the Microsoft Office Suite, safety databases (eg, ARISg, Oracle AERS, Clintrace, etc.), and the MedDRA coding dictionary.
- Must be effective working in a fast-paced environment and possess good judgment.
- Must have high work ethic and integrity, be flexible, and quickly adapt to changing priorities.