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Librarian

Fortrea
Pune, IND
Full-time
Junior · 2+ years experience
Onsite
Discovered 2 weeks ago
Communication

Full Job Posting

Key Responsibilities

  • Design and execute comprehensive literature search strategies using databases such as PubMed, Embase, Scopus, and Web of Science.
  • Monitor and retrieve relevant publications for Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), and Development Safety Update Reports (DSURs).
  • Maintain documentation of search strategies, results, and rationale to support regulatory audits and inspections.
  • Collaborate with pharmacovigilance scientists, medical writers, and regulatory affairs teams to ensure timely and accurate reporting.
  • Stay current with Good Pharmacovigilance Practices (GVP), especially Module VI, and other global safety regulations.

Qualifications

  • Master’s degree in Library Science, Information Management, or a related field.
  • Minimum 2 years of experience in biomedical literature searching, preferably in a pharmaceutical or healthcare setting.
  • Familiarity with medical indexing systems (e.g., MeSH, Emtree) and Boolean logic.
  • Understanding of pharmacovigilance principles and regulatory frameworks (e.g., EMA, FDA, ICH).
  • Strong attention to detail and ability to manage multiple priorities under tight deadlines.
  • Preferred Skills
  • Experience with reference management tools (e.g., EndNote, Mendeley).
  • Knowledge of drug safety databases and signal detection methodologies.
  • Certification in pharmacovigilance or drug safety (e.g., DIA, PV training programs) is a plus.
  • Analytical thinking: Strong analytical skills to evaluate complex medical information and identify relevant safety data.
  • Communication: Excellent written and verbal communication skills to interact with internal teams, regulators, and medical professionals.
  • Learn more about our EEO & Accommodations request here.

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