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Safety Data Exchange Agreement Specialist - GCM, PVAM & SDEA

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: May 3, 2021

Job Description:


Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.

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

The SDEA Specialist, Process & Agreements is responsible for supporting the activities performed within this group. This position assists the Sr. Manager within Process & Agreements in the effective oversight of Safety Data Exchange Agreements (also known as Pharmacovigilance Agreements) with business partners, including development, tracking, and closure activities. The Specialist will also support continuous improvement activities for SDEA processes. This position will interact with internal and external customers, along with functional team members.

Essential Functions

  • Responsible for the maintenance of the global SDEAs, assisting in the initial draft, review and update activities
  • Entry of applicable information for SDEAs into SDEA tracking tool
  • Supports corrective/preventative actions development relevant to skill area as a result of inspection and audit outcomes.
  • Prepares and/or reviews relevant Jazz controlled documents to ensure alignment and global PV requirements are met
  • Undertakes additional projects, as assigned, in support of business goals
  • Tracks and communicates SDEA revisions required for review
  • Assist Sr. Manager with SDEA amendment updates
  • Assist Sr. Manager in the communication of new, revised or terminated agreements to the organization
  • Preparation of SDEA Summary Documents
  • Provide responses to SDEA related queries

Required Knowledge, Skills, and Abilities

  • Knowledge of and experience with FDA and EU and international PV regulations
  • Knowledge of and a minimum of 3 years of experience with pharmacovigilance activities and processes
  • Experience in drafting Safety Data Exchange Agreements OR Pharmacovigilance Agreements required
  • Experience in working with business partners/distributors/contractors
  • Excellent teamwork and interpersonal skills are required with proven ability to effectively lead (multiple) projects
  • Able to perform a variety of complicated tasks with a wide degree of creativity and latitude
  • Must possess excellent communication (oral and written) and problem-solving skills
  • Strong computer skills in Word, Excel, and Power Point

Required/Preferred Education and Licenses

  • Bachelor's degree or equivalent degree required
  • Life sciences or related discipline is preferred

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.

Keywords: Jazz Pharmaceuticals, Palo Alto , Safety Data Exchange Agreement Specialist - GCM, PVAM & SDEA, Other , Palo Alto, California

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