Director, Safety Data Sciences (people manager)

AbbVie; North Chicago (IL); In loco; USD 161.000 - 305.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

401(k)

Descrizione del lavoro

AbbVie in North Chicago, IL seeks a Director, Safety Data Sciences (people manager) to lead a team responsible for surveillance, signal detection, and safety data analyses across therapeutic areas. You will partner with TA heads, safety physicians, and data science teams to drive risk assessment and regulatory submissions.

The role requires strong leadership, regulatory knowledge, and the ability to mentor scientists while delivering high-quality safety analyses and reports globally.

Competenze

• Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing).
• Bachelor's degree plus 7 years of clinical/pharma or safety work experience.
• Master's or Doctorate plus 5 years of clinical/pharma or safety work experience (e.g. MPH, PharmD, or Masters in a Health Science).
• Knowledge of the drug development process, including clinical trials, regulatory requirements, and safety reporting.

Mansioni

• Oversee surveillance and regulatory activities in the designated Therapeutic Area (TA).
• Lead Safety Data Sciences team within the Product Safety Team (PST) and contribute to risk assessment.
• Manage safety data scientists and contract staff to ensure high-quality work.
• Collaborate with Therapeutic Area Heads and safety/clinical colleagues to develop analyses.
• Author and review global safety reports and safety sections of CSRS, CDash, and Risk Plans.
• Mentor and train safety scientists and ensure timely, compliant deliverables.
• Identify partnerships to increase efficiency and lead process improvements.

Conoscenze

People management

Regulatory knowledge

Data analysis

Project management

MS Word

Excel

Formazione

Health sciences degree (e.g., Pharmacy, Epidemiology, Nursing)

Bachelor's degree + 7 years experience in clinical/pharma or safety

Master's or Doctorate + 5 years experience (e.g., MPH, PharmD)

Descrizione del lavoro

Director,Safety Data Sciences(people manager)

• Full-time
• Salary Min: 160500
• Salary Max: 305000
• Workday Global Grade: 21
• Compensation: USD 160,500 - USD 305,000 - 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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Purpose:This positionpartners 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 safetyto 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,strategizesand 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.

• 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,mentoringand 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 leadsand TA physiciansas needed. Able to problem solve and anticipate problems.

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 this posting 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 and until 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 applicants seeking a reasonable accommodation, click here to learn more:

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