Drug Safety Coordinator
US-Emeryville, CA OR Remote
Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.
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.
- Under supervision, perform follow-up on adverse event reports received in collaboration with DSP associates and case managers.
- Must be able to recognize and understand when to triage or consult with supervisor when requiring guidance.
- Maintain training files/tracker and initiate training for the Drug Safety & Pharmacovigilance Team
- Under supervision, work with Information Technology to track and route tickets to support the safety database.
- 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.
- Create and/or maintain multiple tracking spreadsheets, and routinely provide metrics and trending reports.
- Assist in supporting audits and inspections; create and maintain audit-ready files, including training files.
- Maintain both electronic and paper files, including management of the central Drug Safety & Pharmacovigilance file room.
- Responsible for daily on-site filing and retrieval of adverse event case files and maintenance of the client adverse event file storage facilities within the Case Management Center.
- 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.
- Perform other operational tasks in support of Drug Safety & Pharmacovigilance Operations as required by management.
- May assist with tracking and reconciliation of incoming adverse event reports, investigator letter distribution, regulatory submissions, etc.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Other duties as assigned.
- BS in biological/life sciences and 1 year of relevant experience in the health, clinical, biopharmaceutical, or relevant industries, such as pharmacy technician or nursing assistant.
- 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 ethics and integrity, be flexible, and quickly adapt to changing priorities.
- Ability to stand or sit for prolonged periods.
- Must be able to perform repeating motions that may include the wrists, hands and/or fingers.
- Occasional travel required, as needed.
- Full COVID-19 vaccination is required for this position.
Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.