Pharmacovigilance Leadership Role
1 week ago
About Arcellx
Arcellx is a pioneering clinical-stage biotechnology company that has revolutionized the field of cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases.
Our mission is to destroy cancer and advance humanity by creating safer, more effective, and accessible cell therapies.
We are committed to fostering a fun, diverse, supportive, and informal environment that allows our team members to excel in their roles.
The Core Values That Guide Us
At Arcellx, we live by four core values: Character, Audacity, Determination, and Collaboration. These values are the foundation upon which we build our work environment, and we seek candidates who embody these qualities.
The Pharmacovigilance Team
The Pharmacovigilance team plays a critical role in ensuring the safety of our products. As a leader in this field, you will be responsible for advancing and maintaining safety governance oversight for all Arcellx products.
You will provide strategic leadership for the function, overseeing all PV-related activities performed by external vendors, and ensuring appropriate documentation and governance frameworks are in place.
Key responsibilities include:
- Leading the development of departmental SOPs
- Collaborating with cross-functional partners to provide input and oversight for safety and PV
- Ensuring the timely assessment and reporting of individual case safety reports (ICSRs) by the PV vendor
- Overseeing aggregate reporting, management of benefit-risk profiles, signal detection, and risk management and mitigation plans for Arcellx products
- Representing PV in audits with health authorities and development partners
What We're Looking For
We require a candidate with a strong background in drug safety and pharmacovigilance, including experience in PV management roles. A degree in RN/BSN, MS, MPH, PharmD, or equivalent is preferred.
The ideal candidate will have:
- 8+ years of combined experience in biotech/pharma drug safety and pharmacovigilance
- At least 5 years of experience in PV management roles
- Immuno-oncology therapeutic area experience or equivalent required
- Advanced working knowledge of safety & pharmacovigilance regulations and guidelines
- Experience with safety databases such as Argus or ARISg and MedDRA coding
- Strong vendor management, leadership, and communication skills
Benefits
Arcellx offers a highly competitive compensation package, including an estimated salary range of $275,000 - $305,000 per year, based on factors such as years of experience and education.
Additionally, we offer:
- An annual bonus based on company goals
- An equity (RSU) grant
- Relocation assistance for roles requiring it
- 100% coverage for medical, dental, and vision for team members and dependents
- Unlimited vacation
- A 3-day weekend every month
- Fully-paid parental leave for up to 6 months
- Tuition reimbursement
- 401k employer contribution
About Our Culture
Arcellx is a dynamic and inclusive workplace where talented individuals can grow and thrive. If you share our passion for innovating cell therapy and making a difference in the lives of patients, we encourage you to explore this exciting opportunity.
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