Librarian

Role Overview

We are looking for a meticulous and research-oriented librarian to bolster our pharmacovigilance department by performing detailed literature searches to uncover safety signals, adverse drug reactions, and new safety data. This position plays a vital role in ensuring compliance with international regulatory standards and safeguarding our product safety profiles.

Key Responsibilities

• Develop and carry out comprehensive search strategies across databases such as PubMed, Embase, Scopus, and Web of Science.
• Track and collect relevant articles for Individual Case Safety Reports, Periodic Safety Update Reports, and Development Safety Update Reports.
• Document search methodologies, outcomes, and reasoning to support audits and inspections by regulatory authorities.
• Work closely with pharmacovigilance scientists, medical writers, and regulatory affairs personnel to guarantee timely and precise reporting.
• Keep updated with Good Pharmacovigilance Practices, notably Module VI, alongside other international safety regulations.

Qualifications

• Master's degree in Library Science, Information Management, or equivalent fields.
• At least 2 years’ experience in biomedical literature searching, preferably within pharmaceutical or healthcare sectors.
• Knowledge of medical indexing schemes such as MeSH and Emtree and proficiency using Boolean operators for search refinement.
• Familiarity with pharmacovigilance concepts and regulatory frameworks like EMA, FDA, and ICH guidelines.
• Exceptional attention to detail with the capability to juggle multiple priorities and meet stringent deadlines.

Preferred Skills

• Hands-on experience with reference management software like EndNote or Mendeley.
• A background in drug safety databases and signal detection techniques.
• Additional certification in pharmacovigilance or drug safety (such as DIA or PV training) is advantageous.
• Strong analytical abilities to critically assess complex medical literature and extract pertinent safety information.
• Excellent communication skills, both written and verbal, for effective interaction with internal teams, regulatory bodies, and healthcare professionals.

Additional Information

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