DSPV Operations Consultant @Sage Therapeutics, Inc.

[Hiring] DSPV Operations Consultant @Sage Therapeutics, Inc.

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

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Role Description

SAGE Therapeutics is searching for an experienced DSPV Operations Consultant that is a creative, resourceful, and integrative thinker to provide interim Operations support to the Drug Safety & Pharmacovigilance department. The DSPV Operations Consultant will ensure the strategies of the department are executed within global safety legislation and 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 including Clinical Operations & Development, Medical Science, Data Science, Regulatory Affairs & Operations, Quality Systems, and Medical Affairs.

Participates in the review and execution of DSPV Operations safety data collection strategy across clinical trial and commercial programs.
Represents DSPV Operations on clinical development teams, as assigned.
Provides knowledge into clinical and postmarketing teams on the needs and timelines of safety-related organized data collection.
Participates in the creation and dissemination of appropriate safety reporting language in key clinical trial and commercial documents.
Represents DSPV Operations in cross-functional activities to ensure compliance with pharmacovigilance data collection standards.
Provides oversight and review of vendor case processing activities.
Provides sponsor oversight of SAE processing by outsourced vendors.
Actively participates in the quality review of SAEs and SUSARs.
Contributes to the update and review of vendor project plans.
Contributes to projects that involve the implementation of new processes and methods within and across DSPV.
Leads process improvement initiatives and ensures process consistency across DSPV procedures.
Manages reconciliation activities between DSPV and relevant vendors.
Actively participates in cross-functional projects that develop and support strong cross-functional relationships.
Provides support in the development, review, and revision of applicable pharmacovigilance agreements.
Collaborates with internal and cross-function team members in the review and operationalization of new organized data collection programs.
Actively contributes to ongoing inspection readiness activities for DSPV Operations.
Develops and maintains procedures related to the processing and reporting of SAEs.
Identifies deviations and applicable corrective and preventive actions.
Oversees timely submissions of expedited reports to the FDA and other health authorities.
Participates in internal audits and global regulatory inspections as an SME for specific DSPV topics.

Qualifications

Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences required.
Master's degree in health care related profession preferred.
6+ years of direct “hands-on” Drug Safety & Pharmacovigilance experience.
Vendor management experience.
Knowledge of FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance.
Experience using ARISg, Argus, or other Safety Database applications required.
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).
Strong team player that 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.

Requirements

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.
Ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations.
Demonstrated ability to translate strategy into action.
Ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Benefits

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.

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📍	Be aware of the location restriction for this remote position: USA
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DSPV Operations Consultant @Sage Therapeutics, Inc.

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

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