Manager, Safety Systems Management (Remote)

Company: Disability Solutions
Location: Palo Alto
Posted on: September 19, 2024

Job Description:

If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter. Brief Description:The Manager, Safety System Management will be responsible for the management of safety data-related activities in the Drug Safety team such as, but not limited to, generating listings from the safety database, peer review of safety database queries, coordinating safety systems user access & database changes in collaboration with IT, participation in implementation & testing of system changes. This position will work closely with the safety systems Super Users across sites, data listing requestors within Drug Safety, and with business partners from IT and their vendors.

• Essential Functions/Responsibilities
• Excellent working knowledge on pharmacovigilance and drug safety regulations (ICH, GxP)
• Work to streamline and optimize business processes based on industry best practices.
• Generate listings from the safety database, both standard reports and ad hoc queries.
• Conduct peer review of safety database queries for accuracy and completeness of the results.
• Coordinate safety systems user access & database changes in collaboration with IT.
• Participate in implementation & testing of system changes, which may include preparation and execution of test scripts.
• Work closely with the Drug Safety case processing team to ensure consistent data entry processes across all products.
• Participate in updating the data entry manual and associated work instructions when new and/or updated conventions are introduced and train the staff as appropriate.
• Proactively screen ICSRs for data consistency and identify areas of opportunity to enhance data entry processes.
• Work closely with IT and their vendors and Drug Safety staff to troubleshoot, configure, and administer functions on our business applications.
• Collaborate and coordinate with cross-functional team members to assist in the design, review and creation of high-quality safety database output/listings.
• Develop systems for organizing data to analyze, identify and report data and trends.
• May represent Safety systems Management in project team meetings.
• May review clinical protocols to identify impact on safety database, and initiate change requests and configuration as appropriate.
• Support remote and local case processing staff on data-related issues as needed.
• Proactively screen ICSRs for data consistency and identify areas of opportunity to enhance data entry processes.
• Support audits and inspections across global time zones.Required Knowledge, Skills, and Abilities
  • Bachelor's degree and a minimum of three years of experience in supporting Drug Safety case management processes in a pharmaceutical company, or equivalent.
  • Must have a good understanding of Drug Safety regulations specifically US FDA and the EU
  • Must have experience working with standard safety software, with preference for Argus Safety.
  • Experience with reporting tools such as Tableau, Spotfire, Cognos, or Business Objects
  • Familiarity with signal detection and pharmacovigilance processes a plus.
  • Familiarity with SQL and relational databases.
  • Prior experience with computerized systems validation preferred.
  • Must be proficient in Microsoft Excel, Word, and PowerPoint; familiarity with MS Project
  • Must have strong analytical and problem-solving skills, with the associated curiosity to enable solving complex problems with little assistance.
  • Must be self-motivated, detail oriented and able to multi-task in a dynamic fast paced environment.
  • Must possess excellent communication (oral and written) skills regarding both medical and technical topics.
  • Must have strong interpersonal/organizational skills.
  • Must always maintain superior customer service with all users.
  • Must possess the ability to work in a team environment and follow written policies/procedures.
  • Must be comfortable in a fast-paced, demanding work environment.
  • Flexibility to work outside of normal working hours or on-call arrangements to support the global
  • drug safety organization.
  • Limited travel within the US and internationally may be required.
  • Must be able to manage own work, with ability to prioritize, plan and organize work assignments while working under strict timelinesRequired/Preferred Education and Licenses
    • Bachelor's degree in computer science or engineering 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. FOR US BASED CANDIDATES ONLYJazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $116,000.00 - $174,000.00Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

Keywords: Disability Solutions, Palo Alto , Manager, Safety Systems Management (Remote), Executive , Palo Alto, California