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Amgen seeks Literature Review Specialist to Advance Patient Safety
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Thousand Oaks, CA – Amgen, a leading biotechnology company, is actively seeking a dedicated Literature Review Specialist to join its global literature surveillance team. This critical role supports the company’s mission to serve patients by ensuring the safety and efficacy of its innovative medicines through meticulous review of scientific literature. The specialist will play a key role in signal detection and identification of individual case safety reports (ICSRs) for Amgen’s extensive portfolio of products.
Role Overview: Enhancing Global Literature Surveillance
The Literature Review Specialist will be responsible for the weekly review of articles retrieved from Embase, Medline, and BIOSIS, the bibliographic databases used for Amgen’s global literature surveillance. This process is crucial for identifying potential safety signals and ensuring that all marketed products meet the highest safety standards. According to a 2024 report by the World Health Organization, robust pharmacovigilance systems are essential for minimizing risks associated with pharmaceutical products [[ref]].
Key Responsibilities
- Perform weekly reviews of literature results to identify ICSR criteria for marketed products.
- Analyze literature to detect new aggregate safety facts for periodic reports and signal detection.
- Order full-text articles as needed to confirm ICSR criteria or signal detection.
- Flag articles with new aggregate safety information for secondary review by TA Safety.
- Request translations of non-English articles from Local Safety Officers.
- Notify business partners of relevant articles.
- Conduct retrospective quality checks on literature reviews.
- Support audits and inspections.
- collaborate on process betterment initiatives with Case Management and TA Safety.
- Propose system and process improvements.
- Provide training and onboarding to junior staff.
- Perform quality checks on reviews by other staff.
Essential Skills and Experience
Candidates should possess 8-13 years of experience in a pharmaceutical, biotech, or regulatory authority setting, with direct literature review experience being highly preferred. A strong understanding of bibliographic databases and global pharmacovigilance regulations is essential. the role also requires the ability to manage competing priorities,strong knowledge of literature citation management systems,and experience with AI tools. the FDA emphasizes the importance of continuous monitoring and assessment of drug safety profiles [[ref]].
Did You Know? Amgen’s commitment to patient safety extends beyond literature review, encompassing comprehensive risk management and proactive safety monitoring programs.
Periodic Reporting and Quality control
Along with routine literature reviews, the specialist will assist with quality control of periodic reporting activities and support audits and inspections by extracting relevant citations from the literature citation management system.
Benefits of Joining Amgen
Amgen offers a collaborative, innovative, and science-based culture where employees can make a lasting impact on patients’ lives. The company provides competitive benefits and comprehensive Total Rewards Plans aligned with local industry standards. Amgen is committed to fostering an inclusive environment and is an Equal Chance employer.
Pro Tip: Highlight your experience with pharmacovigilance regulations and literature databases in your application to stand out.
Amgen’s Commitment to Innovation and Patient Care
Since 1980, Amgen has been at the forefront of biotechnology, developing innovative medicines in oncology, inflammation, general medicine, and rare diseases. By joining Amgen, you will contribute to a mission that impacts millions of patients worldwide, helping them live longer, fuller, and happier lives.
| Responsibility | Skill |
|---|---|
| Weekly Literature Review | Knowledge of bibliographic databases |
| signal Detection | Ability to identify ICSR criteria |
| Quality Control | Understanding of pharmacovigilance regulations |
| Process Improvement | Collaboration with Case Management and TA Safety |
Apply Now for a Career That Defies Imagination
Amgen encourages qualified applicants to apply for this exciting opportunity to transform their careers while making a difference in the lives of patients. Visit careers.amgen.com to learn more and submit your application.
The Importance of Literature Surveillance in Pharmacovigilance
Literature surveillance is a cornerstone of pharmacovigilance, the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.Continuous monitoring of scientific literature allows pharmaceutical companies to identify potential safety issues early, ensuring that patients receive the safest and most effective treatments. The process involves systematically reviewing published articles, conference proceedings, and other sources of scientific information to detect new or changing safety signals. These signals can then be further investigated to determine their clinical importance and to implement appropriate risk management measures.
Frequently Asked Questions About Literature Review Specialist Roles
- What is the primary responsibility of a Literature Review Specialist at Amgen?
- The primary responsibility involves performing routine weekly reviews of scientific literature to identify potential safety signals and individual case safety reports (ICSRs) related to amgen’s portfolio of products. This ensures continuous monitoring of product safety.
- What databases are used for literature surveillance at Amgen?
- Amgen utilizes Embase, medline, and BIOSIS as the primary bibliographic databases for its global literature surveillance activities.These databases provide a comprehensive source of scientific publications.
- How does Amgen ensure the quality of its literature review process?
- Amgen ensures quality through retrospective quality checks, collaboration with Case Management and TA Safety on process improvements, and by providing training and onboarding to junior staff. Quality checks are also performed on literature reviews conducted by other team members.
- What skills are essential for a Literature Review Specialist at Amgen?
- Essential skills include knowledge of product profiles, the ability to identify ICSR criteria or aggregate safety findings, familiarity with literature citation management systems, and a strong understanding of global pharmacovigilance regulations. Experience with AI tools is also beneficial.
- What experience is required for the Literature Review Specialist position at Amgen?
- The position typically requires 8-13 years of experience in a pharmaceutical, biotech, or regulatory authority setting, with a preference for candidates with direct literature review experience and knowledge of bibliographic databases.
- How does Amgen support its employees’ professional growth?
- Amgen supports professional growth through competitive benefits, a collaborative culture, and opportunities for personal and professional development. They offer comprehensive total Rewards Plans aligned with industry standards.
- What therapeutic areas does amgen focus on?
- Amgen focuses on four main therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Their work in these areas impacts millions of patients annually.
Disclaimer: This article provides information about a job opportunity at Amgen and is not intended to provide medical or legal advice.
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