Senior Manager Pharmacovigilance Assurance
Company: Disability Solutions
Location: New York
Posted on: April 26, 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:This position primarily provides support to the
Clinical and Pharmacovigilance Quality Assurance (CPVQA) function
for Pharmacovigilance (PV) Systems in:
- Leading the preparation for, and hosting of Regulatory
Authority PV System inspections at Jazz's primary U.S. site, and
external audits performed of Jazz.
- Ensuring compliance with global, local and regional PV
regulations and Jazz's policies/proceduresInspection readiness is
focused in GVP, but is not limited to GVP and may include
supportfor Good Clinical Practice, Good Distribution Practice, Good
Manufacturing Practices, and other Marketing Authorization Holder
inspections where there are PV system touchpoints.Essential
Functions/Responsibilities
- Partners with PV system stakeholders in R&D, Tech Ops and
Commercial to monitor trends in regulatory inspection activities to
proactively identify potential areas of risk, and develop proposals
to mitigate against such risks.
- Collaborates with local site teams (e.g., IT, Facilities,
R&D, Administrative Support, etc.) to ensure logistical support
during inspections and audits.
- Prepare subject matter experts, and their back-ups, to present
their functions during audits and aid in creating storyboards.
- Work with business to develop appropriate corrective action /
preventative action against observations from inspections and
audits.
- Track all relevant corrective action / preventative action
details from inspections and audits to completion.
- Escalates issues of critical noncompliance and/or lack of
urgency in remediation to senior leadership.
- Develop and implement monitoring programs to ensure regulatory
requirements for PV/Post- Authorization requirements are complied
with and risks are minimized through coordination of
internal/external audits.
- Support the development of trending analysis of inspection and
audit outcome data to identify business or development program
risks. Provide consultative support to the business with the
purpose of continuous improvement
- Upon notification of a regulatory inspection or internal audit
initiates and supports the inspection team to prepare and submit
pre-inspection document requests, logistics, and execution.
Preforms inspection host responsibilities when required.
- Ensures that company communications are sent regarding the
start and end of inspection activity and provides daily summary to
Sr. Leadership.
- Contribute to the development and execution of Global
PV/Post-Authorization audit strategy, and implementation within the
Quality Management System.
- Coordinate and implement strategic audit plans for
pharmacovigilance and post- authorization commitment activities
that include service providers, vendors, business partner, and
internal audits.
- Evaluate corrective and preventative action (CAPA) findings to
identify quality-related signals and trends for improvement; ensure
adequate and timely closure of CAPAs generated from audits.
- Required Knowledge, Skills, and Abilities
- 5+ years working knowledge / experience of pharmaceutical
experience
- Knowledge of GVP is required. Knowledge of post-authorization
commitment requirements is preferred (Phase IV, PASS Studies) and
Managed Access Programs (PSPs/MRPs, Early access etc.) is
desirable.
- Knowledge and experience with GCP, GLP, and GDP is a plus.
- Advanced inspection experience with FDA, MHRA (or other EU
Competent Authorities); experience with emerging markets Regulatory
Authority such as PMDA a plus.
- Ability to work across geographical boundaries with strong
leadership and ability to inspire colleagues.
- GVP auditing experience is preferred.
- GVP lead auditor certification is desirable.
- Sound judgment and decision-making skills.
- Must be able to influence and motivate others without
authority.
- Action and results orientated.
- Project management skills desirable.
- Required/Preferred Education and Licenses
- Bachelor's degree in a related field is required; Master's
degree in management, leadership or scientific discipline a
plus.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
$124,000-$186,000. 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, Hoboken , Senior Manager Pharmacovigilance Assurance, Executive , New York, New Jersey
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