Manager, Pharmacovigilance Operations

Allogene Therapeutics • South San Francisco, CA

1d • Hybrid

About The Position

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. We are seeking a highly motivated Manager, Pharmacovigilance Operations to join our team. You will provide support to the Allogene Pharmacovigilance department for drug safety operations including safety vendor oversight and management, serious adverse event reporting, support of study teams and projects, oversight of global safety database activities, and collaboration to support risk management and pharmacovigilance for all Allogene Therapeutics Clinical Trials and post marketing (where applicable). You will be interfacing cross-functionally at many levels in the organization as well as with our external vendors. You will be self-motivated, have strong communication and teamwork skills along with a robust ability to work independently, problem solve, manage work priorities, build collaborative relationships, and remain flexible to the needs of the teams and projects. This position will report to the Director, Pharmacovigilance. This role can be remote with frequent to travel to Allogene’s South San Francisco headquarters or can be based out of our headquarters in South San Francisco, CA hybrid onsite 3 days a week.

Requirements

• Bachelor’s degree in life sciences, healthcare, or a related discipline; advanced degree (e.g., RN, BSN, PharmD) preferred
• Minimum of 5 years of pharmacovigilance experience in a pharmaceutical or biotechnology company
• Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
• Proficiency in safety databases and other systems (e.g., Oracle Argus, ARISg, MedDRA, WHODrug, SPEED)
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Ability to work independently and collaboratively in a fast-paced environment and manage multiple projects simultaneously.
• Candidates must be authorized to work in the U.S.

Nice To Haves

• Experience with device safety reporting, eTMF filing, and regulatory inspections is a plus.

Responsibilities

• Assist in Safety Vendor Oversight activities including tracking of KPIs, compliance metrics, and open query metrics.
• Participate in eTMF filing for Allogene studies per TMF plans and procedures.
• Schedule meetings and manage meeting agenda for PV team.
• Support Study Management Team meetings as needed.
• Facilitate the preparation, completion, and submission of periodic safety reports (DSUR, 6M LL, etc.) and other regulatory filing documents.
• Assist in MedDRA and WHODrug coding as needed.
• Collaborate with the preparation and updates to safety section in the Investigator Brochures, RSI, DSURs, Protocols, ICFs, etc.
• Manage Regulatory Reporting Requirements across all studies, ensure all requirements are met by the most current regulations.
• Support projects or other initiatives from cross functional groups and departments
• Support SPEED access requests and maintain the tracker, resolve access issues as applicable, perform monthly reconciliation.
• Support SAE reconciliation between Clinical and Safety databases as needed.
• Manage safety mailbox and provide responses to relevant communications.
• Maintain internal and external distributions lists including providing updates and communications as appropriate.
• Assist in the development and approval of PV SOPs and Work instructions
• Initiate SMP review per schedule
• Liaise with QA for CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs
• Maintain SUSAR tracker in real time, perform monthly reconciliation and identify/resolve issues in timely manner.
• Participate in regulatory inspections and PV audits to ensure quality, integrity and compliance with pharmacovigilance and safety reporting requirements
• Other duties and projects as assigned

Benefits

• annual performance bonus
• equity
• health insurance
• generous time off (including 2 annual holiday company-wide shutdowns)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager