Associate Director, Safety Data Sciences

Allergan; North Chicago (IL); On-site; USD 120,000 - 150,000; Full time

Job summary

AbbVie is seeking a safety-science professional to support the product safety profile across the lifecycle. The role involves signal detection, evaluation, and preparation of summaries for senior management and regulatory authorities globally.

You will collaborate with safety, clinical, and regulatory teams to analyze data from multiple sources, prepare safety documents, and contribute to risk management plans. Strong communication and project management skills are essential.

Qualifications

• Degree in a Health Sciences field (e.g., Pharmacy, Epidemiology, Nursing).
• Experience: 4 years clinical/pharma or safety work (Bachelor level) or 2 years with Masters/PhD.
• Knowledge of drug development, clinical trials, regulatory submission and post-marketing support.
• Regulatory obligations and safety science to support safety decisions.
• Proficiency with safety tools and ability to work in a matrix, multidisciplinary environment.
• Strong written and oral communication; proficient Word/Excel; basic project mgmt; independent worker.

Responsibilities

• Responsible for standard surveillance activities for a product's life cycle by reviewing safety data from trials, safety databases, and literature.
• Collaborates with safety and clinical teams to develop strategies for signal assessments and regulatory requests; analyzes data from multiple sources.
• Uses medical judgment to assess impact of safety issues on benefit-risk; communicates findings to product teams and leadership.
• Prepares and maintains safety sections of Clinical Summary of Safety, CSRs, Company Core Data Sheets, and Risk Management Plans; writes global safety reports.
• Prepares summaries of key safety data for PST, SRB, senior management and other meetings; partners to lead safety initiatives within PPS.
• Mentors and trains new safety scientists; demonstrates regulatory guidelines and SOPs.

Skills

Pharmacovigilance

Cross-functional collaboration

Regulatory awareness

Communication skills

Independent working

Education

Bachelor's degree in Health Sciences

Master's/PhD in Health Sciences

Tools

Microsoft Word

Microsoft Excel

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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html