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.
The Drug Safety Specialist 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.
They 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 Specialist will assist with Deviation and Notice of Event (NOE) documentation and investigation, where necessary.
The Drug Safety Specialist will participate in the set-up and maintenance of adverse event workflow, and be accountable for the development of department policies and standard operating procedures.
In addition, the Drug Safety Specialist may contribute to the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other Jazz Pharmaceutical business areas.
The Drug Safety Specialist may assist in special projects as assigned by the Pharmacovigilance, Quality & Safety (PQS) department management.
Processes adverse event information received by the GCM department
Reviews case information for appropriate distribution to internal and external business partners
May triage incoming cases to determine seriousness for processing and reporting prioritization at the discretion of the GCM department management
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
Raises Deviation and NOE records and completes investigation, corrective and preventative action (CAPA) plan activities as required
Monitoring and management of GCM mailboxes as required
Oversight of daily case volume and prioritisation of urgent cases
Act as a liaison with internal departments and external business partners on GCM operation management issues and clinical study related activities
Ensures compliance with corporate and departmental standard operating procedures and completion of all assigned training on company procedural documents
Other duties as required
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 GCM department management.
As an individual contributor, may serve as a project manager for functional projects or workflows.
May mentor other GCM employees
Participation in Inspections and Audits as identified
Takes responsibility for personal development including keeping up to date with pharmacovigilance practices, legislation and guidelines.
Knowledge of pharmaceutical industry and minimum 2 years’ experience in pharmaceutical safety & case management related areas.
Experience of case entry.
Experience in obtaining, analysing, disseminating, and reporting safety information in compliance with global regulations
Proficiency in standard desktop software programs (Word, Excel, Outlook).
Experience using ARGUS safety database.
Experience using or familiarity with MedDRA
Understanding of medical terminology and ability to summarize medical information
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 be quality oriented and demonstrate consistent attention to detail
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.