Vice President, Pharmacovigilance

Role Summary

Vice President, Pharmacovigilance at Karyopharm Therapeutics. This leadership role provides medical oversight of global pharmacovigilance activities for clinical trials and product development, and holds line management responsibility for the PV department.

Responsibilities

• Ensuring compliance of Pharmacovigilance with GVP, GCP and all applicable global regulations:
• Establish monthly safety reporting compliance metrics (ICSRs, SUSARs, etc.), aggregate and periodic reports (DSUR, ASR) with 100% quality and on-time delivery for in-house and contracted services.
• Develop and ensure adherence to SOPs, work instructions, and business practices within the department.
• Oversee PV Vendor(s).
• Partner with Quality and Regulatory teams to ensure regulatory compliance.
• Maintain PV department inspection readiness.
• Provide guidance for worldwide pharmacovigilance strategies aligned with company goals.
• Line management for the PV department: recruit resources and provide leadership to a team of safety professionals.
• Establish and maintain policies and procedures for the Clinical Drug Safety Department.
• Perform or oversee medical review of SAE reports to ensure accuracy, integrity, and consistency of safety data.
• Manage safety product profiles, including signal detection and risk management activities (SMP documentation) through single-case and aggregate analyses.
• Develop and manage the department budget.
• Evaluate overall safety profile of investigational products and alert clinical teams and senior management to potential safety issues.
• Support clinical operations on safety-related issues as required.
• Provide input and review responses to regulatory questions related to safety pharmacovigilance.
• Develop and author safety sections of NDAs, MAAs, and other regulatory submissions as required.
• Support safety sections of clinical documents, including protocols, annual reports, and final study reports.
• Support development and maintenance of product benefits-risk profile.
• Evaluate and interpret adverse event/serious adverse event reports for use in safety pharmacovigilance submissions.

Qualifications

• MD degree required
• 8‚Äì10 years of pharmacovigilance experience in a global environment
• Knowledge of pharmaceutical development
• Working knowledge of FDA, EU and ICH guidelines for safety reporting and processing in clinical trials
• Expertise in SAE analysis, SAE coding, and signal detection
• Familiarity with safety databases, including ARGUS
• Strong organizational, management, teamwork and interpersonal skills
• Excellent clinical judgment and ability to communicate complex clinical issues
• Experience influencing management and stakeholders to achieve outcomes
• ICARE values (Innovation, Courage, Urgency, Resilience, Energy)
• Strong written and verbal communication skills

Skills

• Pharmacovigilance leadership
• Medical review of SAE reports
• Risk management and SMP development
• Signal detection and safety data analysis
• Regulatory submissions and safety sections of NDAs/MAAs
• Budget development and management

Education

• MD degree