Role Summary
The Senior Director, Safety and Pharmacovigilance (PV) is responsible for leading, building, and managing Safety and PV activities across all clinical programs at Artiva, ensuring compliance with global regulatory requirements and internal standards.
Responsibilities
- Oversee global Safety and PV activities to ensure compliance with applicable regulatory requirements and guidances.
- Oversee adverse event case processing (ICSRs) and aggregate reporting (DSUR) to ensure high-quality safety reports are submitted within required timelines to regulatory agencies and external stakeholders.
- Lead the preparation and review of safety-related sections for clinical and regulatory documents.
- Partner with Clinical Leads and Medical Monitors for medical review and reporting of individual adverse events and reactions, ensuring appropriate assessment of case seriousness, causality, expectedness, medical coding, and case follow-ups.
- Serve as the primary liaison with internal departments and external partners on Safety and PV related issues.
- Develop and update drug safety forms and templates, ensuring harmonization with clinical operation functions during study start-up and conduct of clinical studies.
- Manage Safety and PV vendor relationships, execution of responsibilities, and ensuring compliance with safety data processing and submission activities.
- Ensure effective serious adverse event (SAE) reconciliation between clinical and safety databases.
- Develop and implement Safety and PV process improvements, tools, systems, and procedures.
- Provide input into responses to regulatory inquiries and safety issues.
- Contribute to the development and updates of safety documents, including core data sheets, investigator brochures, labels, and RMPs as required.
- Participate in regulatory inspections and internal audits and author responses to findings.
- Maintain close interactions and oversee the assessment and performance of assigned personnel, fostering an environment of professional development.
- Able to work cross-functionally with other development and functional areas in the organization.
Qualifications
- Minimum of 5 years of Drug Safety and PV experience in a biopharma or biotech organization.
- A health care professional background (e.g., MD, RN, BSN, PharmD, Physician Assistant) is required.
- Strong understanding of global Safety and PV regulations, including EU and US regulations and ICH guidelines.
- Excellent understanding of Good Pharmacovigilance Practices, GCP, clinical trial methodology, and medical terminology.
- Proficiency with safety databases (e.g. Argus), regulatory regulations, and MedDRA coding.
- Excellent interpersonal, organizational, and communication skills.
- Strong project management and problem-solving abilities.
- Attention to detail and quality-focused approach.
- Proven ability to prioritize workload and meet deadlines.
- Demonstrated initiative and flexibility through effective, innovative leadership.
- Strong negotiation and communication skills, with the ability to operate in a global, culturally diverse environment.
- Ability to work effectively both independently and in a team setting.
Additional Requirements
- Willingness to travel as required.