Drug Safety Associate III
Jazz Pharmaceuticals - Palo Alto, CA

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THE POSITION

As a member of the Drug Safety and Pharmacovigilance department, 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 Jazz Pharmaceuticals 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. This Drug Safety Associate III will participate in the set-up and maintenance of adverse event workflow, monitor department policies and standard operating procedures, and manage the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other Jazz Pharmaceutical business areas. In addition, the Drug Safety Associate III will assist with the preparation of internal and external reports (PSURs, PADERs, etc.) and production and distribution of routine department metrics. Drug Safety and Pharmacovigilance staff are members of cross-functional teams and assist in the work of other groups as needed. The Drug Safety Associate III will coordinate the department’s workflow, and assist in special projects as assigned by the Head of the Drug Safety and Pharmacovigilance department.
RESPONSIBILITIES
  • Processes adverse event information received by the Drug Safety and Pharmacovigilance department and assists in the preparation of internal and external reports
  • Triages incoming cases to determine seriousness for processing and reporting prioritization
  • 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
  • Assists in the compilation of individual and aggregate reports (PSURs, PADERs, etc.) per U.S. and international regulations as assigned
  • 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 mentor and train Drug Safety Associates and other department staff as needed
  • 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
  • Drug Safety Managers may assist in signal detection activities as assigned by the Pharmacovigilance and Core Safety Information Committee

Job Requirements :
  • BS/BA degree in a health related (e.g., RN/BSN, RPh/PharmD) or biological science related field (e.g., B.S. in Biology) and 5-7 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
  • Must demonstrate accountability for delivery of results and have good problem-solving and decision making skills
  • Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
  • Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
  • Must have the ability to work collaboratively as part of a team in a fast-paced dynamic environment

Jazz Pharmaceuticals is an Equal Opportunity Employer.

Jazz Pharmaceuticals - 20 months ago - save job - block
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