Associate Director, Safety Data Sciences

ABBVIE; South San Francisco (CA); On-site; USD 142,000 - 269,000; Full time

Job summary

AbbVie in South San Francisco, CA, seeks Associate Director, Safety Data Sciences to lead surveillance and signal management across the product lifecycle. You will collaborate with cross-functional teams to prepare regulatory submissions and safety communications for senior management and authorities.

The role requires a Health Sciences degree with pharmacovigilance knowledge, strong data analysis, and leadership to mentor junior staff.

Qualifications

• Degree in a Health Sciences field (e.g., Pharmacy, Epidemiology, Nursing).
• Knowledge of drug development, regulatory requirements, and safety science.
• Ability to work in a multidisciplinary, matrix team with minimal supervision.

Responsibilities

• Perform standard surveillance for products across lifecycle by reviewing safety data.
• Collaborate with safety/clinical teams to develop signal assessment strategies.
• Analyze data for signal assessment and prepare materials for regulatory requests.
• Assess impact of safety issues on benefit-risk and inform risk minimization.
• Prepare safety sections of CSRs, CSMS, and risk management plans.
• Mentor and train new safety scientists.

Skills

Surveillance

Signal detection

Pharmacovigilance

Data analysis

Regulatory awareness

Education

Health Sciences degree

Masters/PhD in related field

Tools

MS Word

MS Excel

Regulatory databases

Job description

Associate Director, Safety Data Sciences

• Full-time
• Salary Min: 141500
• Salary Max: 268500
• Workday Global Grade: 20
• Compensation: USD 141500 - USD 268500 - yearly

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 atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

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.

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.