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.
- Analyzes data to support signal assessment and contributes to ad hoc regulatory safety requests using data from multiple sources with supervision.
- Utilizes medical judgment to determine the impact of identified safety issues on the compound/ 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.
- Support strategy development, authorship and review of global aggregate safety reports in accordance with regulatory requirements and standard operating procedures with supervision.
- Prepares summaries of key safety data for PST, SRB, senior management, Advisory and other similar meetings with supervision.
- 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.
- Degree in a Health Sciences (e.g., Pharmacy, Epidemiology, Nursing);
o Bachelors + 2 years clinical/pharma or safety work experience
o Masters or doctorate, 1-2 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.
- Understanding of tools, standards and approaches used to efficiently evaluate drug safety is desirable, not required.
Familiar with 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 guidance from manager
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.
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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 , please visit us at . Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
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