AbbVie

Associate Director, Safety Data Sciences

AbbVie • $138K — $165K *
Irvine, CA 92620In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Degree in Health Sciences (Pharmacy, Epidemiology, Nursing) or equivalent;
  • 4 years of clinical/pharma or safety work experience (if Bachelors) or 2 years (if Masters/Doctorate);
  • Proficient knowledge of the drug development process and regulatory requirements;
  • Experience with drug safety evaluation tools and methodologies;
  • Strong oral and written communication skills with project management capabilities.

Responsibilities

  • Conduct standard surveillance activities for product life cycles;
  • Collaborate with safety and clinical teams for signal assessments;
  • Analyze data independently for signal assessment and regulatory safety requests;
  • Communicate findings to product teams and leadership regarding risk minimization;
  • Prepare and maintain safety sections of clinical documents;
  • Lead safety-related initiatives within the organization;
  • Mentor and train new safety scientists.

Benefits

  • Paid time off including vacation, holidays, and sick leave;
  • Medical, dental, and vision insurance;
  • 401(k) retirement plan options;
  • Participation in long-term incentive programs.
Full Job Description
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.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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