Medical Review Specialist
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Bucharest, Bucharest
- Research & Development
- Pharmacovigilance
- Full-time
This vacancy has now expired. Please see similar roles below.
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The primary focus of this position is the medical review of clinical trial serious adverse events (SAEs) including causality assessment and company analysis development.
Main Responsibilities:
- Performs causality assessment of adverse events in post-marketing individual case safety reports.
- Performs medical review of clinical serious adverse events (SAEs).
- Develops company analysis for suspected unexpected serious adverse reactions (SUSARs).
- Responsible for accurate and timely communication with all clinical trial stakeholders.
- May serve as secondary lead for therapeutic area.
- Understands safety profile of assigned AbbVie products and development compounds as well as safety aspects of relevant therapeutic area drugs and patient populations.
- Understands disease state for each indication within assigned AbbVie products and development compounds.
- Understands global regulations, processes and practices.
- Contributes as requested to PSEQ initiatives and deliverables.
- MD with a minimum of 3 to 5 years of clinical experience post residency
- Effectively analyze and guide analysis of clinical data and epidemiological information
- Effectively present recommendations / opinions in group environment both internally and externally
- Write, review and provide input on technical documents
- Work collaboratively and lead cross-functional teams
- Ability to lead cross-functional teams in a collaborative environment
- Core Competency in using Microsoft Office 365 applications such as Outlook, Word, Excel, OneNote, and PowerPoint
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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