Senior Director, DSPV Operations @Sage Therapeutics, Inc.

[Hiring] Senior Director, DSPV Operations @Sage Therapeutics, Inc.

Mar 21, 2025 - Sage Therapeutics, Inc. is hiring a remote Senior Director, DSPV Operations. 💸 Salary: unspecified. 📍Location: USA.

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Role Description

The Senior Director, DSPV Operations position is responsible for directing and managing Sage Therapeutics' infrastructure and staff to support the operational aspects of the pharmacovigilance system, adhering to all global regulatory requirements and internal processes and procedures.

Manage DSPV Operations and DSPV Systems personnel.
Establish and define annual goals for direct reports aligned with Sage corporate goals.
Ensure direct reports have defined goals related to professional growth and development.
Provide ongoing evaluation of goals throughout the year utilizing the Sage Checkpoint process.
Develop and maintain a robust onboarding curriculum for new DSPV Operations & Systems staff.
Monitor and manage monthly vendor invoices for accuracy prior to approval.
Represent DSPV as a leader on project teams and committees, as needed.
Collaborate and provide support on resource planning for DSPV Operations and Systems personnel.

Vendor/License Partner Oversight

Evaluate and approve DSPV CSP staff credentials prior to joining the Sage project.
Provide vendor oversight and management for all outsourced PV activities, including case processing and reporting.
Contribute to the development and/or maintenance of all relevant procedural documents.
Oversee timely submissions of expedited reports to the FDA and other health authorities.
Assist with identification of deviations and applicable corrective and preventive actions.
Lead the development, review, finalization, and revision of all PVAs.

Inspection Readiness

Contribute to the coordination of a DSPV inspection readiness program.
Collaborate with relevant stakeholders in responding to DSPV operations and systems findings.

Safety Database Management

Serve as the business process owner (BPO) of the safety database and other supporting DSPV tools.
Ensure that the PV Database supports the department needs.
Provide oversight of MedDRA updates in collaboration with the relevant PV vendor.
Support signal detection, benefit-risk profile assessment, and aggregate reporting activities.

Study Start-Up/ODCP Activities

Oversee the set-up of applicable new safety projects.
Provide support and guidance to other DSPV personnel responsible for specific compounds.
Collaborate and provide support in the review and operationalization of new organized data collection programs (ODCPs).

Qualifications

Bachelor’s degree in life sciences, pharmacy, nursing, or equivalent health experience; advanced life sciences degree or MBA preferred.
5-7+ years of experience in a Drug Safety & Pharmacovigilance role in the pharmaceutical industry; previous managerial role in Drug Safety.

Preferred Qualifications

Demonstrated ability to create, evaluate, and maintain effective business processes.
Thorough knowledge and experience in all aspects of safety reporting for clinical trials and marketed products.
Strong knowledge and experience with currently available drug safety database systems.
Operational expertise with ARGUS or other safety databases.
Excellent oral and written communication skills.
Strong interpersonal and leadership skills.
Experience working with all levels of management and consulting with key business stakeholders.
Strong team player with a customer service approach.
Attention to detail and the ability to work individually and within a multi-disciplinary team.

Core Values

Put People First
Improve Lives
Cultivate Curiosity
Do Right
Forge New Pathways

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Senior Director, DSPV Operations @Sage Therapeutics, Inc.

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Salary 💸 unspecified	Remote Location USA
Job Type full-time	Posted Mar 21, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Senior Director, DSPV Operations @Sage Therapeutics, Inc.

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