Senior Director, DSPV Operations

General Scope and Summary

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, and adheres to all global regulatory requirements and internal processes and procedures. Primary responsibilities of this role include, but are not limited to, Sage case management, data review, document development/review including procedures for the accurate and timely processing, review and reporting of adverse events from investigational Sage compounds and Sage marketed products. This role also provides support for new and/or revised pharmacovigilance agreements (PVAs), Organized Data Collection Programs (ODCPs), and resource planning for the DSPV Operations & Systems personnel.

Roles and Responsibilities

Management:

• Directly manage DSPV Operations and DSPV Systems personnel.

• Establish and define annual goals for direct reports that are aligned with Sage corporate goals. Ensure direct reports have defined goals related to professional growth and development. Actively 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 and actively participate in the interview process and onboarding of new DSPV members, as needed.

• 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, including but not limited to, those related to the processing and reporting of SAEs from clinical trials and marketed products to ensure compliant PV processing and reporting.

• Oversee timely submissions of expedited reports to the FDA and other health authorities.

• Assist with identification of deviations and applicable corrective and preventive actions to maintain compliance with all applicable global regulations.

• Lead the development, review, finalization, and revision of all PVAs in collaboration with the applicable internal DSPV and cross-functional stakeholders.

Inspection Readiness:

• Contribute to the coordination of a DSPV inspection readiness program in collaboration with other DSPV and non-DSPV stakeholders.

• Collaborate with relevant stakeholders in responding to DSPV operations and systems findings and implementing corrective actions from internal audits and/or health authority inspections.

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, including specific workflows and reporting/querying functionalities.

• Provide oversight of MedDRA updates in collaboration with the relevant PV vendor.

• Support signal detection, benefit-risk profile assessment, and aggregate reporting activities for overseeing the provision of accurate reports from the PV database.

Study Start-Up/ODCP Activities:

• Oversee the set-up of applicable new safety projects, including development of study specific Safety Management Plans and set-up of safety systems and database configurations in the PV database to accommodate these trials and products.

• Provide support and guidance to other DSPV personnel responsible for specific compounds, as needed.

• Collaborate and provide support in the review and operationalization of new organized data collection programs (ODCPs)

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. 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 are key. 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 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 and implement procedures, systems, and tools to maximize resources within a Drug Safety department.

• 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, document management systems and QC tools. This also includes MedDRA and linked technologies.

• Operational expertise with ARGUS or other safety databases.

• 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.

• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.

• Strong team player that has a customer service approach and is solution-oriented.

• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

• 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.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.

Employment Type:

Job ID:

#Biotechnology #Careers #ThisIsSage

Equal Opportunity Employer. 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

EEO is the Law - Supplement

Pay Transparency Nondiscrimination

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.