Librarian

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Role Overview:

The Medical device Literature Librarian identifies and retrieves published information on clinical safety and performance outcomes for medical devices. He/She supports systematic literature reviews, evidence-based research, and regulatory submissions by identifying, retrieving, and organizing scientific literature using advanced search strategies and bibliographic databases. The Medical device Literature Librarian should meet the following professional standards to ensure competence in executing regulatory literature surveillance activities:

Key Responsibilities:

• Conduct comprehensive literature searches across databases like OVID, MEDLINE, PubMed, Embase, Scopus, Web of Science, and Cochrane.
• Apply inclusion/exclusion criteria to screen abstracts and full texts.
• Identify and collate PICOS Population, Intervention, Comparison, Outcomes, and Study design.
• Maintain documentation for PRISMA flow diagrams and audit trails.
• Practical understanding of Boolean logic, MeSH/Emtree vocabularies, and proximity searching.
• Organize and manage references using tools like EndNote, Mendeley, or Zotero and Screening tools (DistillerSR)
• Perform Article Ordering through ReprintsDesk, CCC (Copyright Clearance Center), Article Galaxy.
• Maintain and update internal knowledge repositories and databases.
• Collaborate with medical writers, regulatory affairs, and clinical teams to understand literature needs.
• Assist in preparing bibliographies and reference lists for regulatory submissions and publications.
• Train internal teams on literature search strategies and database usage.
• Develop guides and SOPs for literature review processes.
• Ensure compliance with internal SOPs and external regulatory requirements.

Required Skills & Qualifications:

• PhD in Life Science, Biomedical Engineering, Bachelor's/Master's degree in Library Science (MLS/MLIS), Information Science, Pharma D, Master of Pharmacy, or any related science field.
• Strong experience with biomedical databases and Boolean search strategies.
• Familiarity with systematic review methodologies (e.g., Cochrane, PRISMA).
• Excellent organizational and documentation skills.
• Excellent verbal and written communication skills.
• Experience in pharmaceutical, clinical research, or healthcare settings is a plus.
• Knowledge and good understanding of MEDDEV 2.7/1 (Revision 4), EU MDR 2017/745.
• Strong therapeutic area expertise in Orthopedics, Surgery, Cardiovascular, Neurovascular and electrophysiology will be an added advantage.