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- Triages incoming SAE information in order to fulfill timely reporting according to the authority/regulatory requirements.
- Participate in safety surveillance activities for assigned products; and also in area projects/goals. Identify and escalate problems to manager.
- Collecting, analyzing, and triaging Adverse Events including reporting Serious Adverse Events to IND safety including follow-up.
- Timely assessment of adverse event coding for consistency and accuracy of coding.
- Timely, accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians.
- Interface with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, and Pharmacovigilance to assure query resolution.
- Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards and with minimal revision required upon review.
- Work closely with study-specific contacts such as; Clinical Safety Manager, clinical research organization, clinical research associates, data management, and pharmacovigilance.
- Responsible for clinical safety capture and report, as workload responsibilities are study-related and have a major impact on regulatory compliance and product safety profile.
- Follow scientific arguments and identify safety data needs and adhere to resolution of data completeness regarding all aspects of clinical safety that impact product approval, safety signal identification, and patient safety.
- Bachelor's degree with related health science background preferred, RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.
- 2 years clinical experience is required.
- Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues.
- Sound understanding of product labeling/literature, including safety profile.
- Able to apply clinical knowledge to adverse event data collection and assessment.
- Competent in ability to present adverse event data, orally and in writing.
- Adheres to policies and regulations.
- Must be Computer proficient (Windows, Word, Excel).
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
Skills Required
- Bachelor's degree in health science or related field preferred
- 2 years clinical experience
- Understanding of ICH/FDA regulations
- Experience in presenting adverse event data
- Computer proficiency with Windows, Word, Excel
AbbVie Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
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Retirement Support — 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
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Parental & Family Support — Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
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Healthcare Strength — Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.
AbbVie Insights
What We Do
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.
