Vice President, Pharmacovigilance

Role Summary

Vice President, Pharmacovigilance. Responsible for the medical oversight of global pharmacovigilance activities across clinical trials and product development. Provides leadership for all PV activities related to clinical trials and clinical development products.

Responsibilities

• Ensure PV compliance with GVP, GCP and all applicable global regulations.
• Establish monthly safety reporting compliance metrics for individual cases (e.g., ICSRs, SUSARs), aggregate data, and periodic reports (e.g., DSUR, ASR), ensuring 100% quality and timeliness for in-house and contracted services.
• Develop and ensure SOPs, work instructions, and related business practices are written and followed by the department.
• Provide oversight of PV vendors.
• Collaborate with Quality and Regulatory teams to ensure compliance with regulations and processes.
• Maintain inspection readiness of the PV department.
• Provide guidance for worldwide pharmacovigilance strategies aligned with Karyopharm’s goals.
• Hold line management responsibility for the PV department: recruit resources and lead a stable team of safety professionals.
• Establish and maintain policies and procedures for the Clinical Drug Safety Department.
• Perform or oversee medical review of serious adverse event (SAE) reports to ensure accuracy, integrity, completeness of safety information, and consistency of medical coding.
• Manage safety product profiles, including signal detection and risk management activities through the assessment of single-case safety reports and aggregate trend analysis.
• Develop and manage the department budget.
• Continuously evaluate the overall safety profile of investigational products, serving as the product safety expert and partnering with medical monitors to raise safety issues to the clinical team and senior management.
• Support clinical operations teams with respect to safety-related issues as required.
• Provide input and review of responses to regulatory questions related to safety pharmacovigilance activities.
• Develop and author safety sections of NDAs, MAAs, and other marketing applications as required.
• Support safety sections of clinical documents, including the safety portions of protocols, annual reports, final study reports, and other documents as needed.
• Support development and maintenance of the product benefit-risk profile.
• Evaluate and interpret adverse event/serious adverse event reports and other documents for use in safety pharmacovigilance submissions.

Qualifications

• MD degree required
• Knowledgeable of pharmaceutical development
• 8-10 years of pharmacovigilance experience in a global environment
• Working knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing safety reporting and processing for clinical trial environments
• Expertise in SAE analysis, SAE coding, and signal detection
• Familiarity with common safety databases, including ARGUS
• Strong organizational, management, teamwork and interpersonal skills
• Excellent clinical judgement and ability to communicate complex clinical issues in a scientifically sound and understandable way
• Experience working with all levels of management and consulting with key business stakeholders, with ability to influence for greater outcomes
• Embrace our ICURE values: Innovation, Courage, Urgency, Resilience, Energy
• Strong written and verbal communication skills