Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Pharmacovigilance, Signal detection, Signal evaluation, Risk management, Benefit-risk assessment
The Senior Scientist, R&D Chemistry, works under limited supervision and uses knowledge of scientific techniques to design and develop new cleaning and disinfection/sterilization products in compliance to new product dev…
Skills: Analytical chemistry, Formulation chemistry, Medical device development, Research and development, Laboratory instrumentation
Benefits: Health insurance Paid time off 401(k) matching Dental insurance Job Summary The Systems Analyst is responsible for the optimization, administration, and support of the organization’s core business applications.…
Skills: EHR systems analysis, eClinicalWorks, Workflow mapping, Data migration, Clinical reporting
Director, Medical Staff Administration - Fountain Valley / Placentia Linda - FT Days
Irvine, California, United States · On-site
Senior
Who We Are UCI Health is one of California's largest academic health systems and the clinical enterprise of the University of California, Irvine. Established on July 1, 1976, UCI Health has grown into a 1,461-bed health …
Skills: Credentialing, Privileging, Peer review, Medical staff governance, Regulatory compliance
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each…
Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system in…
Skills: Food preparation, Staff supervision, Inventory management, Sanitation, Customer service
Marketing Manager, Upstream TEER Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit …
Skills: Upstream marketing, Strategic planning, Voice of customer, Market research, Product development
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues …
Skills: Manufacturing operations, Team coordination, Six sigma, Lean manufacturing, Regulatory compliance
Unit Ambassador - Thank you for your interest. Please note, the purpose of this posting is to recruit for on-going and future positions. Pay Rate: $23.09-34.64/ per hour Join the transformative team at City of Hope, wher…
Skills: Clerical support, EKG monitoring, Data entry, Record-keeping, Patient care assistance
Senior Principal Mechanical Engineer (HTI) - JJMT Electrophysiology
Irvine, California, United States · On-site
$122k–$213k/yr
Senior+
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Job Summary Responsible for performing failure analysis of customer returned products, newly manufactured products, and prototype products, with the intent of root cause isolation of full device system issues or sensor a…
Senior Manager RA US Advertising and Promotion - Hybrid
Irvine, California, United States · Hybrid
$125k–$237k/yr
Senior
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Regulatory affairs, Advertising and promotion, FDA regulations, Compliance, Strategic planning
Job Summary The Senior Human Resources Business Partner serves as a strategic advisor to executive and senior leadership across R&D, Quality & Regulatory, and General & Administrative (G&A) functions, shaping people and …
Skills: Strategic HR Business Partnering, Organizational Design, Workforce Planning, Succession Management, Leadership Development
TAE Life Sciences (TLS) is a biologically targeted radiation therapy company focused on developing novel treatment to improve the lives of patients with difficult-to-treat cancers. TLS has developed breakthrough technolo…
Skills: System testing, Verification and validation, Medical device development, Design controls, ISO 13485
TAE Life Sciences (TLS) is a biologically targeted radiation therapy company focused on developing novel treatment to improve the lives of patients with difficult-to-treat cancers. TLS has developed breakthrough technolo…
Skills: System testing, Verification and validation, Medical device design controls, Technical writing, Problem-solving
Location: Irvine, CA Shift: Sunday - Thursday OR Tuesday - Saturday The Scientist Level 1 will report directly to the Laboratory Lead/Manager and after training will perform routine testing in compliance with laboratory …
Who We Are Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has prod…
Are you looking to broaden your nursing skills and explore new clinical specialties here at Hoag Hospital? Look no further, as part of the Irvine Telemetry team, you’ll have the opportunity to train across multiple high …
Skills: Telemetry, Critical care, Neurosurgical care, Stroke management, Neuro monitoring
Per Diem House Supervisor-Clinical Care Operations-Variable Shift
Irvine, California, United States · On-site
Mid level
Who We Are UCI Health is one of California's largest academic health systems and the clinical enterprise of the University of California, Irvine. Established on July 1, 1976, UCI Health has grown into a 1,461-bed health …
What is the opportunity? We are hiring a Regional Sales Director to lead a diverse and elite biopharma selling team. With a laser focus on the customer, this role will set the standard of ownership and accountability for…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$142k–$269k/yr
Full-time
bachelor degree, postgraduate degree
Paid time off, Medical insurance, Dental insurance, Vision insurance, 401(k), Long-term incentive programs
Posted 22d ago
~40 hrs/week
Responsibilities
The Associate Director is responsible for standard safety surveillance activities, including signal detection and evaluation throughout the product lifecycle. They also lead the preparation of regulatory safety reports and collaborate with cross-functional teams to manage benefit-risk profiles.
Requirements
Candidates must hold a degree in Health Sciences with at least 2 to 4 years of relevant clinical, pharmaceutical, or safety experience. Proficiency in pharmacovigilance regulations and the ability to analyze complex safety data are essential for this role.
Full job description
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Job Description
This position can be based at any AbbVie hub location including: Lake County, IL, Irvine, CA, South San Francisco, CA, Florham Park, NJ.
This position partners with cross functional stakeholders in support of the product safety profile and benefit risk throughout product lifecycle through signal detection, signal evaluation, and preparation of written and verbal summaries of signal management activities and risks to patient safety to present to senior management and regulatory authorities globally.
Responsibilities
Responsible for standard surveillance activities for a product’s life cycle (one or more assigned compounds and products) through review of safety data from clinical trials, safety databases, and the literature.
Collaborates with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sources.
Independently analyzes data for signal assessment and leads preparation of materials of ad hoc regulatory safety requests using data from multiple sources.
Utilizes medical judgment to determine the impact of the safety issue on the product’s benefit-risk profile.
Communicates findings of surveillance activities and safety assessments to product teams and leadership to inform on necessary risk minimization activities, including label changes.
Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plan.
Independently authors, strategizes and reviews global aggregate safety reports in accordance with regulatory requirements and standard operating procedures
Independently prepares summaries of key safety data for PST, SRB, senior management, Advisory and other similar meetings
Partners to lead safety-related activities/initiatives internal to PPS.
Proficient in pharmacovigilance regulations, guidelines, and company standard operating procedures
In depth understanding of compounds within assigned therapeutic areas, including safety profile and where applicable, labeling, literature, clinical and regulatory issues.
Mentors and trains new safety scientists
Qualifications
Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing);
o Bachelors + 4 years clinical/pharma or safety work experience
o Masters or doctorate + 2 years clinical/pharma or safety work experience (e.g. MPH, PharmD, PhD, or Masters in a Health Science)
Knowledge of the drug development process which includes conducting clinical trials, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.
Demonstrates ability to connect regulatory obligations and safety science to support safety decision making.
Understanding of tools, standards and approaches used to efficiently evaluate drug safety is desirable.
Serves as a resource to cross-functional colleagues by soliciting input and providing recommendations and conclusions. Demonstrates effectiveness in working in a multidisciplinary, matrix team situation.
Demonstrates effectiveness in working in a multidisciplinary, matrix team situation
Effective oral and written communication skills with the ability to manage multiple projects simultaneously .
Microsoft WORD and EXCEL skills and Basic Project Management skills.
Able to work independently with minimal direct supervision.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
Allergan is now part of AbbVie.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
Health CareBiopharmaEducationBiotechnologyMedicalUniversitiesPharmaceutical
How many Healthcare jobs are open in Irvine, CA right now?
There are currently 1,118 open healthcare positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Irvine, CA?
Companies currently hiring include UCI Health, Edwards Lifesciences, City of Hope, Allergan, Hoag Health System, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Irvine, CA?
Yes — 200 of the 1118 open healthcare positions offer remote or hybrid work (69 remote, 131 hybrid).
How do I apply for Healthcare jobs in Irvine, CA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.