Senior Specialist, Drug Safety

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary The Senior Drug Safety Specialist will perform ICSR and SAE case processing; ensure timely and accurate reporting of SUSARs to regulatory agencies. Serve as the Pharmacovigilance (PVG) representative for study teams and assist fellow staff in the preparation of periodic reports and any ad hoc reports as necessary. This role will also serve as mentor to other PVG staff, ensure data integrity, system performance, and compliance with global regulations and internal SOPs, and perform any other tasks as needed to support the PVG team. Essential Functions

• Manage activities to address safety issues for global and domestic clinical studies, and direct PVG team efforts for any safety review committee (SRC) and Drug Safety Monitoring Board (DSMB) activities.
• Triage ICSRs and Clinical trial SAEs, and evaluates data for completeness, accuracy, and regulatory reportability.
• Process ICSRs and SAEs in the Safety database, write narratives, and prepare for regulatory submission as required.
• Perform literature surveillance activities for marketed and investigational products.
• Mentor PVG staff.
• Ensure the integrity of ICSR and SAE data, including performing QC of cases entered by PVG staff.
• Serve as PVG representative on study teams.Â
• Manage clinical study project set-up/close-out.
• Represent PVG in ImmunityBio internal and external team meetings.
• Coordinate coding and complete reconciliation processes.
• Resolve complex problems through in-depth evaluation of various factors and collaboration with stakeholders.
• Implement and optimize PVG processes to enhance efficiency and regulatory compliance.
• Maintain up-to-date knowledge of required therapeutic areas and of current applicable global PVG regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.).
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities. Education & Experience
• RN, Pharmacist, BS or BA degree in Health Sciences or health science related field, with 5+ years of drug safety surveillance and/or pharmacovigilance experience is required.
• Experience with both Post-Marketing and Clinical case processing required.
• Proficient with medical terminology is preferred.
• Safety database experience required (with ARISg) is preferred.
• Medical writing experience with PSURs, DSURs, SDEAs preferred. Knowledge, Skills, & Abilities
• Expert global knowledge of GCPs and regulatory requirements.
• Expert knowledge and strong command of global pharmacovigilance requirements.
• Ability to coordinate complex global and domestic studies.
• Effective problem-solving ability and effective project management skills.
• Effective mentoring skills and ability to train and lead others.
• Knowledge of international safety reporting processing.
• Broad based therapeutic knowledge.
• Excellent oral and written communication skills.
• Excellent Attention to detail and organization skills.
• Ability to work within a team and independently as needed.
• Excellent analytical and technical skills, including the ability to comprehend and integrate scientific data from a variety of sources. Working Environment / Physical Environment
• This position works on-site or remote based on the candidate’s geographic location.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• Must possess mobility to work in a standard office setting and to use standard office equipment, includ

Apply tot his job Apply To this Job