Note: The job is a remote job and is open to candidates in USA. Allogene Therapeutics is a clinical-stage biotechnology company developing allogeneic CAR T-cell therapies for cancer and autoimmune disease. The Manager, Pharmacovigilance Operations supports drug safety operations, including vendor oversight, adverse event reporting, safety database activities, regulatory reporting, and pharmacovigilance activities across clinical trials and applicable post-marketing programs.
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
Skills
- Bachelor's degree in life sciences, healthcare, or a related discipline
- 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
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S
- Advanced degree (e.g., RN, BSN, PharmD)
- Experience with device safety reporting, eTMF filing, and regulatory inspections
Benefits
- Annual performance bonus
- Equity
- Health insurance
- Generous time off, including 2 annual holiday company-wide shutdowns
- Remote work option with frequent travel to Allogene’s South San Francisco headquarters
- Hybrid onsite work 3 days a week option
Company Overview