Director, Safety Data Sciences (people manager)

BioSpace; North Chicago (IL); On-site; USD 240,000 - 320,000; Full time

Job summary

AbbVie is seeking a safety leadership professional to partner with cross functional stakeholders in monitoring product safety across the lifecycle. You will drive signal detection, evaluation, and risk communication to senior management and regulators globally.

You will lead a team of safety data scientists, mentor colleagues, and prepare key safety documents while ensuring compliance with global regulations. Strong communication and strategic planning are essential.

Qualifications

• Degree in Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
• Bachelors + 7 years pharma or safety experience or Masters/PhD + 5 years.
• Knowledge of drug development, regulatory requirements, and safety reporting.
• Ability to connect regulatory obligations to safety decisions.
• Experience influencing senior management and cross-functional partners.
• Familiarity with safety data analyses and standard operating procedures.
• Strong written and oral communication, multi-project management.
• Experience with team mentoring and resource optimization.

Responsibilities

• Oversee surveillance and regulatory activities in a Therapeutic Area.
• Lead a Safety Data Sciences team within the Product Safety Team.
• Provide oversight of both FTEs and contract personnel.
• Collaborate with Therapeutic Area heads and physicians to shape safety strategies.
• Author and review global aggregate safety reports per regulatory standards.
• Assess impact of safety issues on benefit-risk profile using medical judgment.
• Prepare safety sections for CSRs, Investigator's Brochures, and risk plans.
• Ensure deliverables align with company standards and regulations.
• Lead safety initiatives with internal and external partners.
• Prepare concise safety summaries for leadership and committees.
• Mentor new safety scientists and develop colleagues.

Skills

Drug safety

Regulatory knowledge

Communication skills

Leadership

Stakeholder collaboration

Problem solving

Independent work

Mentoring

Strategic planning

Data analysis

Team resource management

Clinical trial familiarity

Regulatory submissions

Documentation writing

Communication with senior management

Education

Health sciences degree

Bachelor’s degree with 7+ years pharma/safety experience

Master’s or Doctorate in Health Science

Tools

Microsoft Word

Microsoft Excel

Basic Project Management

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

Purpose: 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 oversight of surveillance and regulatory activities and deliverables in your designated Therapeutic Area (TA).
• Leads a team of Safety Data Sciences in their role on the Product Safety Team (PST) within a given TA; contributes to the benefit risk evaluation and to safety risk management.
• Provide oversight and actively manages full time employee (safety data scientists) and contract support personnel.
• Key collaborator with Therapeutic Area Heads, safety and clinical physicians and Data and Statistical Sciences to develop strategies for routine and ad hoc safety data analyses.
• Independently authors, strategizes and reviews global aggregate safety reports in accordance with regulatory requirements and standard operating procedures
• Utilizes medical judgment to determine the impact of the safety issue on the product’s benefit-risk profile.
• Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plans.
• Assure deliverable alignment to current company standards and global regulations for products/compounds assigned to direct reports.
• Leads safety-related activities/initiatives internal to PPS and with external partners.
• Independently prepares summaries of key safety data for PST, ADT, senior management, Advisory and other similar meetings.
• Trains new safety scientists and mentors established colleagues.

Qualifications

• Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing);
• Bachelors + 7 years clinical/pharma or safety work experience
• Masters or doctorate + 5 years clinical/pharma or safety work experience (e.g. MPH, PharmD, 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.
• Experience in working directly with and influencing senior management including functional heads
• Identifies strengths and weaknesses of team members to further develop their skills through training, mentoring and learning opportunities.
• Optimizes use of team resources and ensures quality and timeliness in team contributions.
• Prior experience with people management desired.
• Identifies new partnerships throughout Abbvie to increase efficiencies
• Initiates strategic plans for deliverables and leads process improvements
• 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 seeking guidance from manager and PST leads and TA physicians as needed. Able to problem solve and anticipate problems.

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 this posting 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 and until 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.

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