Associate Director, Safety Data Sciences

Allergan; South San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a pharmacovigilance professional to manage safety signal assessment and regulatory support across the product lifecycle. The role is based at a hub location including South San Francisco, CA, and collaborates with cross-functional teams to prepare safety documentation and present risk insights to senior management.

Responsibilities include surveillance of safety data, regulatory requests, safety report preparation, and contributing to safety sections of key documents.

Qualifications

• Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
• Knowledge of the drug development process and regulatory requirements for safety.
• Understanding of tools and approaches to evaluate drug safety; multidisciplinary collaboration.
• Effective oral and written communication with ability to manage multiple projects.

Responsibilities

• Responsible for standard surveillance activities for a product’s life cycle based on safety data.
• Collaborates with safety and clinical teams to develop signal assessment strategies and regulatory requests.
• Analyzes data for signal assessment and prepares materials for ad hoc regulatory safety requests.
• Communicates findings to product teams and leadership to inform risk minimization activities.
• Prepares safety sections of Clinical Safety documents and Risk Management Plans.
• Mentors and trains new safety scientists.

Skills

Oral and written communication

Independent work

Multitasking across projects

Education

Degree in Health Sciences

Bachelor's degree + 4 years clinical/pharma or safety experience

Masters or Doctorate + 2 years clinical/pharma or safety experience

Tools

Microsoft Word

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