Sr. Safety Scientist - Full Time

Employment Type: Full time

About Alira Health:

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Position Overview:

The Sr. Safety Scientist is an important member of the Alira Health Clinical team. This person provides technical and process-related support to safety management (clinical trial and post-market) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). The Sr. Safety Scientist is responsible for case receipt, processing, data entry, and query resolution, as well as development of project-specific safety procedures, workflows, and templates. The Sr. Safety Scientist has client-facing responsibilities and provides mentoring to team members. The Sr. Safety Scientist should have experience in multiple therapeutic areas and extensive hands-on safety database experience.

Key Responsibilities:

• Manages the receipt and processing of all serious adverse event (SAE) and unanticipated adverse device effect (UADE) reports from a clinical trial.
• Performs accurate data entry of SAE/UADE information in the safety database and tracking systems (Oracle Argus or ArisGlobal LifeSphere Multivigilance preferred).
• Reviews SAEs/UADEs for completeness, accuracy, and appropriateness for expedited reporting.
• Drafts safety narratives and Individual Case Summary Reports (ICSRs).
• Codes adverse events and medical history accurately using MedDRA and codes medications with WHODRUG.
• Determines expectedness/listedness against appropriate label.
• Identifies clinically significant information missing from initial reports and ensures its collection.
• Initiates, tracks, and resolves requests for follow-up information from clinical sites.
• Ensures all cases receive appropriate medical review.
• Prepares follow-up correspondence and consults with the medical staff accordingly.
• Ensures all cases that require expedited reporting are processed swiftly and appropriately within required timelines.
• Provides QC of adverse event reports for other members of the safety team.
• Assists in the development of project-specific safety procedures, workflows, and templates.
• Assists in project-specific safety database set-up, development of data entry guidelines, and user acceptance testing.
• Creates and maintains project-specific working files.
• Maintains a strong understanding of safety database conventions.
• Works with data management teams on reconciliation of safety data.
• Monitors workflow for assigned studies and programs to ensure all deadlines are met.
• Along with senior pharmacovigilance team members, prepares Medical Monitoring Plans, Safety Plans, Data Migration Plans, and Pharmacovigilance Plans.
• Participates in internal, client/sponsor, and other meetings as required.
• Complies with ICH GCP guidelines, FDA regulations, and company SOPs.
• Manages and resolves conflicting priorities to deliver on commitments.
• Performs additional duties as assigned.

Desired Qualifications & Experience:

• BS/BA from an undergraduate program, registered nurse, or an equivalent combination of education and 5 years minimum of Safety and Pharmacovigilance experience.
• Prior experience processing AE/SAE reports, generating narratives, generating and resolving safety queries, and experience with regulatory submissions to competent authorities.
• Comprehensive understanding of AEs/SAEs and ability to train others to recognize the required standards per ICH GCP guidelines; submit to client; and liaise with other cross-functional groups within the agreed/stated timelines.
• Expert level knowledge of global regulatory requirements.

Referral Information:

Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.