The Drug Safety Associate III is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations and standard operating procedures and guidelines.
The Drug Safety Associate III will perform accurate computer data entry of identified adverse event information and ensure the uniform and timely processing and reporting of adverse events to regulatory authorities.
The Drug Safety Associate III may participate in the set-up and maintenance of adverse event workflow, and monitor department policies and standard operating procedures.
In addition, the Drug Safety Associate III will manage the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other business areas.
The Drug Safety Associate III may assist in special projects as assigned by the Drug Safety and Pharmacovigilance department management.
Processes adverse event information received by the Drug Safety and Pharmacovigilance department and assists in the preparation of internal and external reports
May triage incoming cases to determine seriousness for processing and reporting prioritization at the discretion of the Drug Safety and Pharmacovigilance department management·
Reviews case information for appropriate distribution to internal and external business partners
Performs accurate computer data entry of identified adverse event information and ensures the uniform and timely processing and reporting of adverse events to regulatory authorities
Reviews adverse event information received for completeness and consistency, initiates case follow-up activities/AE query management, and independently generates narratives in accordance with department processes
Adheres to company templates and guidelines for documentation and communications
Performs quality control activities to ensure complete and accurate case information has been entered into the drug safety database
Follows company processes and guidelines for case management and closure activities
May participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures
May assist in coordinating the department's workflow and assist with special projects under the direction of the Drug Safety and Pharmacovigilance department management.
Act as a liaison with internal departments and external business partners on Drug Safety and Pharmacovigilance operation management issues and clinical study related activities
Ensure compliance with corporate and departmental standard operating procedures
May distribute completed regulatory reports to RA, ClinOps and other as needed to meet regulatory reporting timelines
As an individual contributor, may serve as a project manager for functional projects or workflows
Performs other activities as directed by Drug Safety and Pharmacovigilance management
BS/BA degree in a health related or biological science related field and 5 years of experience, or equivalent combination of education and experience.
Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues
Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
Experience with preparation of investigational and post-marketing regulatory reports
Proficiency in standard desktop software programs (Word, Excel, Outlook)
Experience using ARISg or other safety database applications
Experience using MedDRA
Excellent oral and written communication skills
Highly organized and demonstrates consistent attention to detail