Director, Head of Pharmacovigilance (PV) Operations

About Artiva:

Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.

Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically  modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).

AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in

patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.

Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.

For more information, visit www.artivabio.com.

Job Summary:

This role offers an exciting opportunity to build a dynamic PV operations team and contribute to the safety and efficacy of Artiva’s products in clinical development. The Director, Head of Pharmacovigilance (PV) Operations will lead, build, and manage PV operations activities, ensuring compliance with global regulatory requirements and internal standards. If you have a passion for drug safety and a proven track record in pharmacovigilance, risk management, and compliance, we encourage you to apply.

Essential Duties and Responsibilities:

• Oversee the global PV system to ensure compliance with applicable regulatory requirements and guidance.
• Overseeing 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

• Partners with clinical Medical Monitors for medical review and assessment of individual adverse drug reaction reports, ensuring appropriate assessment of case seriousness, labeledness/expectedness, medical coding, and case follow-up

• Serve as the primary liaison with internal departments and external partners on PV operational issues.
• Develop and update drug safety forms and templates, ensuring harmonization with clinical operation forms during study start-up and during the maintenance phase as required.
• Manage PV vendor relationships, execution of responsibilities, and ensuring compliance with safety data processing and submission activities.
• Lead the preparation and review of safety-related sections for clinical and regulatory documents.
• Ensure effective SAE reconciliation between clinical and safety databases.
• Develop and implement 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’s brochures, labels, and RMPs as required.
• Participate in regulatory inspections and internal audits, authoring responses to findings.
• Oversee the assessment and performance of assigned personnel, fostering an environment of professional development.
• Ability to work cross-functionally with other development and biopharma functional areas

Requirements:

• Minimum of 10 years of PV experience, with at least 5 years in successful management.
• Strong understanding of global PV regulations, including EU and US regulations, ICH guidelines, and GCP.
• A health care professional background (e.g., MD, RN, BSN, PharmD, Physician Assistant) is preferred. Bachelor’s degree in health sciences, life sciences or biotechnology required
• Past oncology drug development experience is preferred.
• Extensive experience in drug safety and PV within biopharma environment or clinical research organization with successful management experience
• Strong 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.
• Ability to work effectively both independently and in a team setting.
• Willingness to travel as required.
• Excellent understanding of Good Pharmacovigilance Practices, international PV regulations and guidance’s, clinical trial methodology, GCP, and medical terminology.
• Strong negotiation and communication skills, with the ability to operate in an international, culturally diverse environment.
• Ability to mentor and coach within the department and cross-functionally.
• Strong attention to detail and quality-focused approach.
• Proven ability to prioritize workload and meet deadlines.
• Demonstrated initiative and flexibility through effective, innovative leadership.

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 cancer patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients.  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!

Artiva Biotherapeutics is an equal employment opportunity employer.

Base Salary: $185,000 - $240,000. Exact compensation may vary based on skills and experience.