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
Support the planning and execution of the safety strategy for Oncology assets during the entire lifecycle of the drug and during due diligence activities.
Main responsibilities
- Supports the Safety Leads and Product Safety Teams (PSTs) to translate nonclinical and clinical safety findings to facilitate benefit-risk decision making and risk mitigation for oncology products in clinical development as well as on the market.
- May lead development and implementation of an asset safety strategy with support of PST-L or management
- Leads 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 oncology assets
- Facilitate scientific connections and interactions, info exchange across assets within the safety teams
- Prepare material on competitive intelligence, current disease state and standard of care for key indications/ disease states
- Supports GPS TA in assigned due diligence activities for Oncology.
- 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 Oncology studies.
- Drives process improvement and change management for the Oncology Safety team in conjunction with enterprise-wide and functional area plans.
Qualifications
- Scientific or clinical degree (e.g. NP/PA, PharmD, MS, PhD, MPH, including combinations)
- 5+ years of experience in Pharmacovigilance / Clinical Development / Development biological Sciences experience in the pharmaceutical industry.
- Proven ability to critically evaluate and interpret complex safety data from oncology clinical trials, supporting informed risk-benefit decision-making
- 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
- Ability to exercise judgment and address complex problems and create solutions across multiple projects
- Must be able to lead and manage through influence.
- Effectively provide input on technical safety documents
- Strong ability to influence individual stakeholders and cross-functional teams in a collaborative environment
- Must possess excellent oral and written English communication skills.
- Ability to work effectively under circumstances of uncertainty and complexity.
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