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Manager, DSPV Quality, Compliance & Training - Massachusetts

 

SAGE Therapeutics

 

 

Full-time

 

Job details

Job Type

Full-time

Indeed's salary guide

       Not provided by employer

       $83.8K to $106K per year is Indeed's estimated salary for manager in training in Massachusetts.

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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

  • Bachelorís 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.

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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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