Drug Safety Specialist
Category: Research & Development | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4411
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 participate in the set-up and maintenance of adverse event workflow, and be accountable for the development of department policies and standard operating procedures.
The Drug Safety Specialist will be responsible for the timely reconciliation and submission of Individual Case Safety Reports (ICSRs) to and from destinations including but not limited to global regulatory authorities, business partners, investigators, and ethics committees in compliance with applicable global regulations/reporting requirements and Jazz Pharmaceuticals standard operating procedures and guidelines. In addition, 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 (PV) 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
- 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
- Participate in the set-up and maintenance of adverse event workflow processes, department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced
- 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.
- Monitors the submission work list in the safety database for cases requiring submission or distribution to regulatory authorities and all relevant reporting destinations by case priority and report due date
- Performs ICSR submissions (in E2B form via Gateway/EVWEB and CIOMS/MedWatch) and monitors E2B submission for transmit status
- Performs E2B submission validation check and manages rejected E2B transmissions via Gateway and ensures successful re-transmission as appropriate
- Works collaboratively with Global Case Management in workflow monitoring and coordinates database action tiems to ensure timely submission and completion
- Works collaboratively with the R&D Quality & Compliance team to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes
- May perform reconciliation activities including but not limited to receipt of all AEs from Business Partners
- BS/BA degree in health related or biological science related field and 1 to 2 years of pharmaceutical drug safety experience.
- Knowledge of pharmaceutical industry and experience in pharmaceutical safety related areas or appropriate combination of education and experience
- Experience of case entry
- Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues
- Experience in obtaining, analyzing, 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
- Flexibility to work outside of normal working hours or on-call arrangements
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.