Scientific Director, Immunology, Global Patient Safety

AbbVie Inc.; North Chicago (IL); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in North Chicago, IL is seeking an experienced immunology safety scientist to plan and execute safety strategies across the asset lifecycle. You will lead development and implementation of safety plans with PST-L or management, and support the review and synthesis of safety data for regulatory documents.

The role requires 5+ years in pharma, deep knowledge of clinical trial methodology, regulatory compliance, and strong ability to influence cross-functional teams.

Qualifications

• Experience in patient safety/pharmacovigilance.
• Knowledge of clinical trial methodology and regulatory requirements.
• Strong analytical and critical evaluation skills.

Responsibilities

• Support planning and execution of safety strategy for immunology assets across lifecycle.
• Lead development and implementation of asset safety strategy with PST-L or management.
• Review and synthesize scientific safety data for regulatory and clinical documents.
• Facilitate information exchange across safety teams and cross-functional partners.
• Prepare competitive intelligence and current disease state material for key indications.
• Draft presentations for internal and external meetings.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and more.
• Drive process improvement and change management for Immunology Safety.
• Perform literature searches and provide analysis and safety action proposals.

Skills

Safety strategy

Cross-functional leadership

Regulatory awareness

Communication skills

Education

Scientific/clinical degree

Tools

Microsoft Office

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,XandYouTube.

Job Description

• Supports the planning and execution of the safety strategy for immunology assets during the entire lifecycle of the drug
• Leads development and implementation of an asset safety strategy with support of PST-L or management
• Supports in the review and synthesis of scientific safety data for critical regulatory and clinical documents — including IB’s DSURs, PSURs, RMPs CSRS, etc. - ensuring medical accuracy, scientific rigor, and clarity of content across immunology assets
• Facilitates scientific connections and interactions, information exchange across assets within the safety teams
• Prepares material on competitive intelligence, current disease state, and standard of care for key indications/ disease states
• Compiles draft slide presentations for internal and external meetings as required
• Interacts with and influences other cross functional departments (e.g. Clinical Development, Statistics, Regulatory Affairs, Clinical Pharmacology, Medical Affairs), as needed, to ensure the successful development, design and implementation of comprehensive safety assessments to support study participants in immunology studies.
• Drives process improvement and change management for the Immunology Safety team in conjunction with enterprise-wide and functional area plans.
• Deep dive in literature search and capable to deliver a strong analysis and summary and proposal for any additional needed safety action

Qualifications

• Scientific or clinical degree (e.g. NP/PA, PharmD, MS, PhD, MPH, including combinations)
• At least 5+years of pharmaceutical industry experience, preferably in patient safety/ PV
• Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols
• Strategic thinking and capacity of analyzing aggregate data and conclude
• Effectively present recommendations / opinions in group environment both internally and externally
• Ability to work effectively under circumstances of uncertainty and complexity.
• Proven ability to critically evaluate and interpret complex safety data from clinical trials, supporting informed risk-benefit decision-making
• Strong ability to influence individual stakeholders and cross-functional teams in a collaborative environment
• Must possess excellent oral and written English communication skills.
• Work collaboratively and lead cross-functional teams
• Good communication and influence skills
• Good organization and mastering Microsoft office tools

Additional Information

• 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/visioninsurance 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 employer 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