Sage Therapeutics Associate Director, Pharmacovigilance Systems Support in EMAIL: Workday@Sagerx.com, Massachusetts
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as the Associate Director of Pharmacovigilance (PV) Systems Support. The Associate Director of Pharmacovigilance Systems Support will report to the Director of Drug Safety and Pharmacovigilance (DSPV) Operations. The successful candidate will partner with the Sage PV Systems Support manager and the vendor’s Managed Services team to plan and lead safety systems projects to completion in collaboration with applicable internal and external stakeholders. This role will support the Sage DSPV team with technical questions and 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 (DEC), Clinical Operations & Development, Medical Science, Data Science, Regulatory Affairs, Regulatory Operations, Quality Systems, and Medical Affairs.
Roles and Responsibilities
Database Support – 60 %
Serve as subject matter expert (SME) for DSPV safety database (Argus) and all integrated applications or tools (e.g. PVQ).
Responsible for overseeing all managed service tickets and ensuring timely and adequate follow-up from the safety database vendor.
Responsible for providing technical expertise related to business process changes as necessary.
Lead and support projects related to Argus and associated PVQ tools, including review and finalization of the scope of work in collaboration with the vendor and applicable cross-functional Sage teams (e.g. disaster recovery testing, database updates, validated report updates, etc.).
Lead all safety database upgrades in collaboration with the safety systems support manager.
Collaborate with the PV Systems Support manager and the vendor’s Managed Services team to support ongoing change controls, including UAT testing.
Collaborate with internal and external stakeholders to assess the potential impact of new and/or updated company-wide systems to the safety database and associated PVQ tools.
Serve as backup support for the safety systems manager.
Vendor Oversight – 20%
Act as the point of escalation regarding Argus and PVQ issues that are not resolved in a timely manner by the vendor’s Managed Services team, and be responsible for escalation to senior leadership as necessary.
Ensure that vendor deviations are promptly drafted upon identification of quality issues and CAPAs are implemented by the safety database vendor, as appropriate.
Evaluate proposed vendor corrections, corrective actions, and/or preventative actions for compliance with applicable regulations, guidelines, and Sage policies.
Actively participate in weekly project team meetings with the safety operations vendor to communicate safety database updates and issues to the team, as needed.
Lead monthly meetings with safety database vendor regarding aging tickets, change control status, issue resolution, and pending action items.
Compliance Oversight – 10%
Oversee new hire training curriculum for Argus safety database and associated PVQ tools.
Actively participate in the interview process and onboarding of new team members, as applicable.
Support the DSPV department with drafting and/or updating internal Sage procedures related to the safety systems, as needed.
Contribute to activities necessary to support and maintain an ongoing state of inspection readiness.
Participate in DSPV audits and Health Authority Inspections as a subject matter expert.
Support compliance oversight, vendor oversight, audit requests and health authority inspections with ad hoc report/listings requests, as needed.
Cross-functional Support – 10%
Represent DSPV Safety Systems as a leader on cross-functional teams and committees, as needed.
Collaborate with cross-functional teams to implement new tools and/or systems to ensure that DSPV business requirements are met.
Contribute to the development, improvement and standardization of new processes and methods.
Oversee aggregate reporting deliverables by the safety systems team in support of signal detection and periodic report deliverables (DSUR, PADER, IND Annual Reports, CSRs, health authority requests, etc.).
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.
Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required.
At least 6 years of direct "hands-on” Drug Safety and Pharmacovigilance experience required, including safety operations and safety database technical experience.
At least 8-10 years of direct “hands-on” Drug Safety and Pharmacovigilance experience required, including safety operations and safety database technical experience.
Safety vendor management experience.
Previous experience leading a safety database upgrade.
Strong knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance, and GxP regulations, including: 21 CFR Part 11, E2B R2/R3 regulatory guidelines, and GVP modules.
Thorough knowledge of Oracle Argus safety system configurations including, but not limited to: reporting rules, workflows, E2B gateways/XML, DTD profiles, and aggregate reporting.
”Hands-on” experience using Pharmacovigilance Query (PVQ) tool or other Safety Database Querying tool(s).
Strong analytical and problem-solving skills with excellent attention to detail.
Strong verbal, written, and technical communication and presentation skills.
Proficiency in standard desktop software programs (Word, Excel, Outlook, and PowerPoint).
Experience working with all levels of management and consulting with key business stakeholders; an ability to influence for greater outcomes.
Previous experience with data visualization and analytics software preferred.
Previous experience leading a data migration preferred.
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.
Possesses strong written and verbal communication skills.
Embraces our Core Values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of Sage.
Number of Openings:
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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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