Associate Director, Drug Safety & Pharmacovigilance Operations

General Scope and Summary

SAGE Therapeutics is searching for an experienced Associate Director, Drug Safety & Pharmacovigilance (DSPV) Operations that is a creative, resourceful, and integrative thinker. The Associate Director will work on projects and processes that 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, but not limited to, Clinical Operations & Development, Medical Science, Data Science, Regulatory Affairs & Operations, Quality Systems, and Medical Affairs.

Roles and Responsibilities

Clinical Trial/Postmarket Programs:

• 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 to ensure these needs are met and incorporated into Sage studies and commercial activities/programs that may generate adverse event data.

• 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 and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical trials and commercial programs.

Vendor Oversight:

• Provides oversight and review of vendor case processing activities.

• Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans.

• Actively participates in the quality review of SAEs and SUSARs following data entry by vendor with a specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, and appropriateness of queries to seek follow-up from the clinical sites.

• Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities.

• Contributes to the update and review of vendor project plans (e.g. SMPs, QMP, Communication Plan).

Cross-Functional Projects:

• 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 and project documents.

• Manages reconciliation activities between DSPV and relevant vendors and business partners to ensure reporting of all adverse event data.

• Actively participates in cross-functional projects that develop and support strong cross-functional relationships and communication.

• Provides support in the development, review, and revision of applicable pharmacovigilance agreements (PVAs), as needed.

• Collaborates with internal and cross-function team members in the review and operationalization of new organized data collection programs (ODCPs).

Inspection Readiness:

• Actively contributes to ongoing inspection readiness activities for DSPV Operations.

• Develops and maintains procedures related to the processing and reporting of SAEs from clinical trials and marketed products to ensure performance and compliant PV processing.

• Identifies deviations and applicable corrective and preventive actions to maintain the compliance with all applicable global regulations.

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

• Identifies deviations and applicable corrective and preventive actions to maintain the compliance with all applicable global regulations.

• Participates in internal audits and global regulatory inspections including FDA/MHRA/EMA etc. as an SME for specific DSPV topics and processes as needed.

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 con