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Manager,
DSPV Quality, Compliance & Training - Massachusetts
SAGE Therapeutics
Full-time
Job details
Job Type
Full-time
Indeed's salary guide
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$83.8K to $106K per year is Indeed's estimated
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Full Job Description
General
Scope and Summary
Sage
Therapeutics is searching for an experienced Manager, DSPV Quality,
Compliance & Training that is a creative, resourceful, and an integrative
thinker. The Manager will report to the Director, DSPV Inspection Readiness
& Compliance. This candidate will assist with the maintenance of the
Global Quality System for DSPV that supports Sage products in compliance with
ICH Guidelines and international regulatory requirements. The successful
candidate will have a proactive and innovative approach and a flexible,
hands-on nature that works with a high sense of urgency. Effective
communication skills will be key, as this role provides an excellent
opportunity for close collaboration with colleagues from other functions such
as Clinical Operations, Medical Science, Data Science, Regulatory Affairs,
Quality Systems, and Medical Affairs.
Roles
and Responsibilities
DSPV
Compliance: 40%
- Assist with monitoring the global DSPV
Quality System through metrics and reports.
- Monitor activities of CROs/business
partners to ensure adherence and compliance with applicable SMPs,
KPIs/Metrics, PVAs, and other contractual agreements.
- Support the review of DSPV and CSP
deviations to ensure accuracy of the root cause and applicable corrective
actions.
- Assist with process improvement
activities related to the documentation of department compliance and the
development of quality assurance plans to improve or maintain data
quality.
- Prepare the DSPV metrics for the monthly
department meeting.
- Collaborate with DSPV colleagues to
support the development and revision of DSPV policies, SOPs, WI, etc.
- Assist with establishing procedures for
documentation of department compliance and the development of quality
assurance plans to improve or maintain data quality.
- Utilize PVQ to generate metrics and
reports to monitor compliance.
Training:
40%
- Ensure new DSPV personnel are assigned
appropriate training as defined by their manager.
- Support oversight of DSPV and CSP
training compliance and collaborate with the internal QA training group.
- Help to maintain the DSPV Training
Curriculum that expands to applicable Sage cross-functional groups.
- Identify relevant quality-related
training needs and conduct training as required.
- Assist with development and revision of
training slides for internal and external use.
- Actively participate in the onboarding
process for new hires.
- Monitor DSPV training compliance monthly
and notify individuals of upcoming and late training.
Internal
Audits and Health Authority Inspections: 10%
- Participate in DSPV audits, Health
Authority Inspections, CSP, and third parties as appropriate.
- Work with DSPV personnel and
cross-functional groups to provide documents requested by
auditors/Inspectors.
- Participate in the ongoing DSPV inspection
readiness initiative.
- Assist with audit responses from
Pharmacovigilance and external partners/vendors and evaluate proposed
corrections, corrective actions, and/or preventative actions for
compliance with applicable regulations, guidelines, and Sage policies.
- Participate as a subject matter expert
(SME) on assigned topics during inspections and audits.
Ad
hoc support: 10%
- Collaborate with other DSPV personnel on
the revision of SOPs and WIs.
- Support the maintenance of the Sage
pharmacovigilance agreement template (PVA) as needed.
- Collaborate with Sage business owners and
Legal to ensure contracts with external parties contain the appropriate
safety language to ensure complete and timely reporting of safety
information to DSPV.
- Negotiate with internal and external
stakeholders as needed to ensure the external party template is aligned
with Sage standards.
- Support maintenance of Sage PV language
templates.
- Support management of the DSPV PVA
tracking tool.
- Monitor PSP/MRP training compliance and
provide live training as needed.
Experience,
Education and Specialized Knowledge and Skills
Must
thrive working in a fast-paced, innovative environment while remaining
flexible, proactive, resourceful, and efficient. Must have excellent
interpersonal skills, the ability to develop important relationships with key
stakeholders, good conflict management and negotiation skills, and the
ability to analyze complex issues to develop relevant and realistic plans,
programs, and recommendations. Must have a demonstrated ability to translate
strategy into action, excellent analytical skills, and an ability to
communicate complex issues in a simple way and to orchestrate plans to
resolve issues and mitigate risks.
Basic
Qualifications
- Bachelor’s degree in life sciences,
pharmacy, nursing, or equivalent health experience; advanced life
sciences degree or equivalent experience.
- 4 years of experience in
Pharmacovigilance compliance.
Preferred
Qualifications
- 6-8 years of experience in
Pharmacovigilance compliance.
- Demonstrated ability to create, evaluate,
and maintain effective business processes and implement procedures,
systems, and tools to maximize resources within a Drug Safety
department.
- Thorough knowledge and experience with quality
systems.
- Excellent oral and written communication
skills.
- Strong interpersonal and leadership
skills and demonstrated ability to manage, motivate, and influence work
behaviors of individuals who are not direct reports.
- Significant prior pharmaceutical or
biotechnology drug development experience.
- Comprehensive knowledge of the
international pharmacovigilance regulations and requirements, including
the Food and Drug Administration (FDA) Code of Federal Regulations Title
21 CFR, European Medicines Agency (EMA) Good Pharmacovigilance Practices
(GPV), and other global regulatory agency regulations and requirements
as applicable.
- Prior experience managing quality and
compliance activities.
- Excellent problem solving and analysis
skills; ability to see trends and convert information to insights.
- Ability to adapt precedent and develop
creative and effective solutions to solve problems.
- Experience in Pharmacovigilance and/or
Pharmacovigilance processes.
- A working knowledge of Argus and PVQ is
preferred.
- Embrace our Core Values: Put People
First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New
Pathways.
- Excitement about the vision and mission
of Sage.
Employment Type:
Employee
Job ID:
R001178
#Biotechnology #Careers #ThisIsSage
All
Sage new hires will be required to provide documentation that they are fully
vaccinated against COVID-19 or, if not, that they are legally entitled to an
accommodation due to a medical condition or a sincerely held religious
belief. Requests for accommodation will be considered on a case-by-case
basis, and Sage will consider, among other things, whether the proposed
accommodation would create an undue hardship.
All
qualified applicants will receive consideration for employment without
discrimination on the basis of race, color, religion, sex, sexual
orientation, gender identity, national origin, protected veteran status,
disability, or any other factors prohibited by law.
EEO
is the Law
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We
value our relationships with professional recruitment firms. To protect the
interests of all parties, and given the large volume of inquiries received
from third-party placement agencies, we are not able to respond to all agency
inquiries. We do not accept unsolicited resumes from any source other than
directly from candidates for current or future positions. Submission of
unsolicited resumes in advance of a signed agreement between our company and
a placement agency does not create an implied obligation and, if an
unsolicited candidate represented by a placement agency is hired, we are not
obligated to pay a fee. Only approved recruitment firms will be allowed to
provide services to Sage Therapeutics, Inc.
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