Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
As a member of the Global Case Processing Team, the Sr. Drug Safety Specialist (with a focus on QC) 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 Sr. Drug Safety Specialist 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 Sr. Drug Safety Specialist will be responsible for performing quality review of individual case safety reports and for providing feedback to team members, working closely with the case processing team and Medical Reviewers to ensure complete and accurate information has been entered into the safety database. The Sr. Drug Safety Specialist may assist in special projects as assigned by the Global Case Processing Team management and may represent the QC Team Lead in internal and external GCM meetings as needed.
- Performs quality control activities including Oversight QC to ensure complete and accurate case information has been entered into the drug safety database, and provides feedback to team members
- Assists QC Team Lead with OQC analysis activities including but not limited to QC Checklist review, upload of QC Checklists for viewing in IVEA, Review of OQC data, analysis and sharing with key stakeholders
- Helps monitor the QC workload to ensure compliance with business partner and regulatory requirements
- Helps identify areas for process improvement (specifically regarding quality) and possible areas for retraining for individuals/team
- Processes adverse event information received by the Global Case Processing Team and assists in the preparation of internal and external reports
- 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
- Follows company processes and guidelines for case management and closure activities
- May triage incoming cases to determine seriousness for processing and reporting prioritization at the discretion of the Global Case Processing Team management
- May distribute completed regulatory reports to RA, ClinOps and other as needed to meet regulatory reporting timelines
- May participate in the set-up and maintenance of adverse event workflow processes, department policies, and standard operating procedures
- May represent QC Team Lead in internal and external meetings as needed
- Adheres to company templates and guidelines for documentation and communications
- Ensure compliance with corporate and departmental standard operating procedures
- As an individual contributor, may serve as a project manager for functional projects or workflows
- Performs other activities as directed by Global Case Processing Team management
Required Knowledge, Skills, and Abilities
- Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
- Experience in safety case processing as well as quality review of individual case safety reports, both in-process and via sampling, is preferred
- Experience with preparation of investigational and post-marketing regulatory reports
- Proficiency in standard desktop software programs (Word, Excel, Outlook) Experience using Argus 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
Required/Preferred Education and Licenses
- Preferred health care professional background, either nurse or PharmD and a minimum of 3 years drug safety experience, or
- BS/BA degree in a health related or biological science related field and 5 years of drug safety experience, or
- Minimum of 7 years of drug safety 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
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.