Senior Specialist, Drug Safety

ImmunityBio•El Segundo, CA

6d•Remote

About The Position

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.

Requirements

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.
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.

Responsibilities

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.
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.

Benefits

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