Jazz Pharmaceuticals

Drug Safety Specialist

UK-Oxford
2 weeks ago
ID
2017-1280
# of Openings
1
Category
Research & Development

Overview

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. 

Position Profile

As a member of the Global Case Management (GCM) department, the Pharmacovigilance Specialist is responsible for participating in the collection, safety review, processing, and reporting of adverse event data in compliance with applicable EMA, FDA and global regulations and Jazz Pharmaceuticals’ standard operating procedures and guidelines. 

The Pharmacovigilance 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. In addition, the Pharmacovigilance Specialist will manage the department relationship with internal and external business partners to meet global regulatory reporting requirements and support other Jazz Pharmaceutical business areas as assigned. Global Case Management staff are members of cross-functional teams and assist in the work of other groups as needed. The Pharmacovigilance Specialist may assist in special projects as assigned by GCM management

Essential Functions
•    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
•    May distribute completed regulatory reports to RA, ClinOps and others as needed to meet regulatory reporting timelines
•    May distribute reports via EVWeb
•    Ensures compliance with corporate and departmental standard operating procedures and completion of all assigned training on company procedural documents 
•    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.
•    Other duties as required


Required Knowledge, Skills, and Abilities 
•    Case processing experience is required.
•    Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are required.
•    Experience 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 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

Required/Preferred Education and Licenses
•    Registered Nurse or Pharmacist (NB certification is required e.g. RN, RPh, PharmD or
•    Health/Biomedical degree (BS, PhD or other related scientific degree/qualification); with knowledge of pharmaceutical industry and strong experience in pharmaceutical safety related areas.
•    Equivalent combination of education and experience


Description of Physical Demands
•    Responsibilities may require working outside of “normal” hours, in order to meet business demands.
 

Jazz Pharmaceuticals is an Equal Opportunity Employer.

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