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Senior Specialist, Drug Safety Submissions Remote
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 Specialist Drug Safety Submission, also known as Pharmacovigilance (PV) Submission Specialist, will focus on ensuring the timely and accurate submission of global safety reports to regulatory authorities and investigators, ensuring drug safety and compliance. This role will also support the PV safety systems programming and maintenance and provide review and expertise for global Safety management plans and other PV study documents to ensure regulatory reporting accuracy. Essential Functions • Prepare and submit safety reports (e.g., Individual Case Safety Reports, Periodic Safety Update Reports and Development Safety Update Reports) to Global regulatory agencies. • Ensure that all submissions adhere to relevant global regulations and guidelines. • Contribute to the development and improvement of global safety reporting processes. • Support the department with EudraVigilance registration issues and maintenance of EudraVigilance accounts. • Manage and maintain safety data, ensuring accuracy and completeness. • Collaborate with cross-functional teams to gather and share safety information. • Participate in audits and inspections related to safety reporting. • Support programming efforts in relation to PV safety systems for regulatory reporting. • Assist with clinical study project set-up/close-out regarding regulatory reporting. • Represent PVG in ImmunityBio internal and external team meetings. • Resolve complex problems through in-depth evaluation of various factors and collaboration with stakeholders. • Maintain up-to-date knowledge of required therapeutic areas and regulatory requirements for SAE processing. • Assist in the generation and writing of DSURs and other periodic reporting. • 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, or Bachelor’s degree in Health Sciences or health science field, with 5+ years of drug safety surveillance and/or pharmacovigilance or comparable relevant experience and training is required OR; • Associate’s degree with 7+ years of drug safety surveillance and/or pharmacovigilance experience or comparable relevant experience and training is required. • Experience in drug safety, pharmacovigilance and global regulatory reporting is required. • Experience in using safety databases and reporting systems is required. • Experience with safety database programming is required. (with ARISg a plus) • Medical writing experience with PSURs, DSURs, SDEAs is preferred. • Oncology experience is preferred Knowledge, Skills, & Abilities • Strong understanding of pharmacovigilance principles, global regulatory requirements and safety reporting guidelines. • Expert global knowledge of GCPs and regulatory requirements. • Ability to coordinate complex global and domestic studies. • Knowledge of international safety reporting processing. • Effective problem-solving ability and project management skills. • Effective mentoring skills and ability to train and lead others. • Knowledge of Broad-based therapeutics • Excellent oral, written communication skills and attention to detail. • 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. • Proficiency with medical terminology. Working Environment / Physical Environment • This position works onsite 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, including a computer. • Lift and carry materials weighing up to 20 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $118,500 (entry-level qualifications) to $130,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $135,000 (entry-level qualifications) to $148,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law. Apply tot his job Apply tot his job
