Senior Director, Safety and Pharmacovigilance (PV)

Senior Director, Safety And Pharmacovigilance

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.

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.

Essential Duties And 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.

Requirements

• Minimum of 10 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.
• Willingness to travel as required.

Why you should apply:

We have a fantastic team and philosophy! We are passionate We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive committed to the diversity of our team and ensuring that all voices are heard.

In addition to a great culture, we offer:

A beautiful facility

An entrepreneurial, highly collaborative, and innovative environment

Comprehensive benefits, including:

• Medical, Dental, and Vision
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company paid holidays, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

If all this speaks to you, come join us on our journey!

Base Salary: $265,000 - $280,000. Exact compensation may vary based on skills and experience.