Senior Director, Drug Safety and Pharmacovigilance Operations

Vendor and Operational Governance

• Provide operational leadership and oversight of DSPV vendors, service providers, consultants, and business partners, including clear definition of roles, responsibilities, deliverables, and escalation pathways.
• Lead or participate in SMTs, vendor governance meetings, cross-functional program teams, and other safety governance forums; track actions, risks, issues, and escalations through resolution.
• Develop and maintain operational plans, SOPs, work instructions, workflows, and other DSPV processes in collaboration with internal stakeholders and external providers.
• Oversee SMPs and VOPs and ensure their implementation across applicable programs and vendors.
• Manage DSPV vendor and consultant budgets, contracts, statements of work, change orders, and invoices.

Safety Data, Surveillance, and Reporting

• Oversee safety-data reconciliation with Data Management, Clinical CROs, and other stakeholders and ensure timely resolution of discrepancies.
• Collaborate with Safety Physicians, Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and external vendors on safety-data review, analysis, reporting, iDMC, and surveillance.
• Prepare and oversee safety reports, listings, narratives, and other data outputs supporting risk management, regulatory submissions, and safety governance.
• Support identification and evaluation of emerging safety concerns
• Support preparation and review of health authority responses and aggregate and expedited safety reports, including DSURs, and 6M line listings.
• Support safety-related sections of CSRs and other clinical documents and provide safety-data outputs for independent Data Monitoring committee meetings.
• Support the Senior Vice President, DSPV, in preparation and facilitation of safety governance and Safety Advisory Committee meetings.

Quality, Compliance, and Inspection Readiness

• Under the direction of the Senior Vice President, DSPV, and in partnership with Quality Assurance, oversee and continuously improve the DSPV QMS.
• Maintain audit and inspection readiness for DSPV activities, systems, vendors, and business partners.
• Lead or coordinate DSPV preparation for internal and external audits and regulatory inspections.
• Oversee CAPAs, remediation activities, and compliance improvements related to DSPV operations.
• Serve as the DSPV subject matter expert for PV compliance and inspection-readiness matters involving case management, safety systems, reporting, workflows, documentation, and KPIs.

Systems, Documentation, and Business Continuity

• Oversee the organization, completeness, and maintenance of DSPV documentation within SharePoint and applicable electronic trial master file systems.
• Partner with IT and relevant vendors to maintain appropriate data-security, data-protection, access, and system-continuity processes for the GSDB and related systems.
• Develop, maintain, and periodically test DSPV business-continuity and disaster-recovery plans for critical systems and operations.

Training

• Lead development and maintenance of the DSPV training curriculum and ensure training requirements support applicable SOPs, processes, systems, and regulatory expectations.
• Oversee vendor training programs and monitor training completion and compliance.

Other

• Perform other duties as assigned.

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.

• Unlimited PTO

• Two, one-week company-wide shutdowns each

• Commitment to provide professional development opportunities.

• Remote working environment with frequent in-person meetings to address complex problems and build relationships.