Senior Specialist/Manager, Pharmacovigilance Operations
Safety | South San Francisco, CA | Full Time
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™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
The Sr Specialist/Manager of PV Operations 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).
- Ensure the day-to-day operational ICSR activities in the workflow processes and timelines are followed in collaboration with the Safety Vendor
- Assist in Safety Vendor Oversight activities including tracking of KPIs, weekly metrics. Also, participate and assist with meeting minutes in weekly meetings, and monthly safety governance meetings
- Ensure all safety reports received from all clinical trials are processed in a consistent and a fully compliant manner
- Assist to ensure clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP)/ PV agreements and safety data exchange agreements (SDEA)
- Assist and support project teams for safety-related areas, including protocol development and study conduct
- Participate and contribute on Study Management Team (SMT) meetings
- Facilitate the preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents
- Collaborate as needed with the preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, etc.
- Support projects or other initiatives from cross functional groups and departments (Clinical Development, Regulatory Affairs, Quality and Toxicity), ensure adequate safety support and timely update of safety information to drug safety physicians
- Supports the development of Allogene Therapeutics Drug Safety infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective
- Assist in the development and approval of PV SOPs and Work instructions
- 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
- Participate in regulatory inspections and PV audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements
- Other duties and projects as assigned. Under the direction of PV leadership, participate in other PV and Risk Management activities, as needed
- Education: Master in life sciences, PharmD, RPh, RN, PA
- Experience: minimum 5-year experience in pharmacovigilance 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)
- Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting, signal detection activities (safety data analysis, categorization, assessment)
- Experience in a drug safety database (e.g Argus)
- Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines
- Ability to work independently, to manage work priorities, to build collaborative team relationships at all levels and remain flexible to the needs of the teams/projects
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.