Manager, Pharmacovigilance Operations, Systems Support Consultant

General Scope and Summary 

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as the Manager, Pharmacovigilance (PV) Operations, Systems Support Consultant that is a creative, resourceful, and integrative thinker. The Manager, Pharmacovigilance Operations, Systems Support Consultant will report to the Associate Director, Pharmacovigilance Operations, Systems Support. The candidate will be a secondary liaison between the safety database vendor’s managed services team, the Sage DSPV department, and the DSPV vendor’s safety operations team. This role will support the Sage DSPV team with technical questions and assistance with troubleshooting issues regarding the safety database and the Pharmacovigilance Query (PVQ) reporting tool.

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 Digital & Enterprise Capabilities, Clinical Operations & Development, Medical Science, Data Science, Regulatory Affairs, Regulatory Operations, Quality Systems, and Medical Affairs.

Roles and Responsibilities

• Act as a secondary liaison between the safety database vendor’s managed services team, the Sage DSPV department, and the DSPV vendor’s safety operations team.

• Create and/or modify reports using PVQ and/or Argus to support compliance oversight, vendor oversight, audit requests, and health authority inspections.

• Support the Sage DSPV department with drafting and/or updating internal Sage procedures as needed.

• Assist with developing and maintaining new hire training curriculum for Argus and PVQ.

• Assist the DSPV team with support for Argus and PVQ questions or issues and escalate issues as needed to the safety database vendor’s managed services team and/or to Sage senior leadership as necessary.

• Track managed service tickets and ensure timely and adequate follow-up from the safety database vendor.

• Ensure that deviations and corrective action reports are drafted by the safety database vendor upon identification of quality issues.

• May assist with special projects related to Argus and PVQ, including review and finalization of the scope of work.

• May assist with annual disaster recovery testing for Argus and PVQ in collaboration with the vendor and applicable cross-functional Sage teams.

• Collaborate with the managed services team to support DSPV requests for safety database and/or PVQ changes.

• Participate in user acceptance testing (UAT) for changes and upgrades to the safety database and for changes and upgrades to other Sage systems that have an impact on the safety database. 

• May assist with routine regulatory intelligence activities related to changes in global reporting requirements to assess the impact on the DSPV systems.

• Support the DSPV department with ongoing MedDRA and WHO Drug Dictionary updates.

• Collaborate with DSPV Operations to ensure that all new and updated clinical trial protocols and associated regulatory authority and license partner reporting rules are configured in the safety database accurately in time for study start-up.

• Support DSPV business owner responsibilities for other AE/PC reporting tools, as required.

• Maintain current knowledge of adverse event reporting process and the safety system and contribute to the development, improvement, and standardization of new processes and methods.

• Contribute to activities necessary to support and maintain a state of inspection readiness, including storyboards and knowledge transfer documentation.

• Generate reports and line listings in support of signal detection and aggregate report deliverables (DSUR, PADER, IND Annual Reports, CSRs).

• Collaborate with other Sage departments to implement new tools and/or systems to ensure that DSPV business requirements are met.

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 identify issues and raise to key stakeholders in order 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, computer science, or other healthcare-related field required.

• 5+ years of direct “hands on” Drug Safety and Pharmacovigilance experience required, including safety operations and safety database technical experience.

Preferred Qualifications

• Safety systems vendor (e.g. managed services team) management experience required.

• Knowledge of FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance.

• “Hands on” experience using Argus or other safety database application(s) required.

• Strong analytical and problem-solving skills with excellent attention to detail.

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

• Strong verbal, written, technical, communication, and presentation skills.

• Proficiency in standard desktop software programs (Word, Excel, and Outlook).

• ”Hands on” experience using Pharmacovigilance Query (PVQ) tool or other Safety Database Querying tool(s) preferred.

• Previous experience with data visualization tool(s) preferred.

• 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.

• 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.

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.