Manager, Safety Systems Management (Remote)
Company: Disability Solutions
Location: San Francisco
Posted on: May 17, 2024
Job Description:
If you are a Jazz employee please apply via the Internal Career
siteJazz 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
www.jazzpharmaceuticals.com 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 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.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 a plus.
- Prior experience with computerized systems validation
preferred.
- Must be proficient in Microsoft Excel, Word, and PowerPoint;
familiarity with MS Project is
- preferred.
- 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.
- 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-$174,000. Individual 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, Novato , Manager, Safety Systems Management (Remote), Executive , San Francisco, California
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