This opportunity is available in Oxford, UK.
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 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
- 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 experience in pharmaceutical safety related areas or appropriate combination of education and experience
- 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 or familiarity with ARGUS or other safety database applications
- 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.