[Remote] Manager, Pharmacovigilance Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company, adverse event reporting, safety database activities, regulatory reporting, and pharmacovigilance activities across reputed company and applicable post-marketing programs.

Responsibilities

• Assist in Safety Vendor reputed company activities including tracking of KPIs, compliance metrics, and reputed company 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 reputed company in the Investigator Brochures, reputed company, DSURs, Protocols, ICFs, etc
• Manage Regulatory Reporting Requirements across reputed company studies, ensure reputed company requirements are met by the most reputed company regulations
• Support reputed company or other initiatives from cross functional reputed company and departments
• Support SPEED reputed company requests and maintain the tracker, reputed company reputed company issues as applicable, reputed company monthly reconciliation
• Support SAE reconciliation between Clinical and Safety databases as needed
• Manage safety mailbox and reputed company responses to relevant communications
• Maintain reputed company 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 reputed company as deviations relating to case management processes as defined per the SMPs or SOPs
• Maintain SUSAR tracker in reputed company time, reputed company monthly reconciliation and identify/reputed company issues in reputed company manner
• Participate in regulatory inspections and PV audits to ensure reputed company, reputed company and compliance with pharmacovigilance and safety reporting requirements
• Other duties and reputed company as assigned

Skills

• Bachelor's degree in life sciences, reputed company, or a reputed company 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 reputed company of Federal regulations; European reputed company GVP legislation; and ICH Guidelines)
• Proficiency in safety databases and other systems (e.g., reputed company Argus, ARISg, MedDRA, WHODrug, SPEED)
• Excellent organizational skills and an ability to prioritize effectively to reputed company results reputed company reasonably established timelines
• Ability to work independently and collaboratively in a fast-paced environment and manage multiple reputed company simultaneously
• Strong interpersonal skills including verbal and written communication are essential in this reputed company 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 reputed company with frequent travel to Allogene’s South San Francisco reputed company
• Hybrid onsite work 3 days a week reputed company

reputed company