Senior Director, Safety and Pharmacovigilance (PV)

Artiva Biotherapeutics; San Diego (CA); On-site; USD 265,000 - 280,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

401(k) Retirement Plan

Paid Time Off (PTO)

Job summary

A clinical-stage biotech company in San Diego is seeking a Senior Director, Safety and Pharmacovigilance. In this role, you will lead Safety activities across clinical programs, ensure compliance with global regulations, and manage vendor relationships. Ideal candidates have a healthcare background and over 5 years of experience in Drug Safety and Pharmacovigilance. Benefits include comprehensive health insurance, paid time off, and flexible spending accounts. The base salary ranges from $265,000 to $280,000.

Qualifications

• Minimum of 5 years of Drug Safety and PV experience in a biopharma or biotech organization.
• Strong understanding of global Safety and PV regulations, including EU and US regulations and ICH guidelines.
• Excellent understanding of Good Pharmacovigilance Practices and clinical trial methodology.

Responsibilities

• Oversee global Safety and PV activities for compliance.
• Manage adverse event case processing and aggregate reporting.
• Serve as primary liaison with internal departments on Safety and PV issues.

Skills

Drug Safety

Pharmacovigilance

Project Management

Communication Skills

Interpersonal Skills

Education

Health care professional background (e.g., MD, RN, BSN, PharmD, Physician Assistant)

Tools

Safety databases (e.g., Argus)

Job description

About Artiva

Artiva is a clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization.

AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren’s Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers.

Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California.

For more information, visit www.artivabio.com.

Job 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.

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 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.
• 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.

Benefits

• 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.