Librarian

Fortrea; Pune District; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Fortrea is seeking a detail-oriented librarian to support our pharmacovigilance team by conducting systematic literature searches to identify safety signals and ADRs. You will handle searches across major databases and assist in ICSR, PSUR, and DSUR reporting with strict adherence to regulatory guidelines.

Ideal candidates hold a Master’s degree in Library Science or Information Management and have at least two years of biomedical literature searching experience, preferably in pharma or

Qualifications

• Master’s degree in Library Science, Information Management, or related field.
• 2+ years of biomedical literature searching experience, preferably in pharma/healthcare.
• Familiarity with MeSH, Emtree, and Boolean logic.
• Understanding of pharmacovigilance principles and regulatory frameworks (EMA, FDA, ICH).

Responsibilities

• Design and execute literature search strategies across PubMed, Embase, Scopus, and Web of Science.
• Monitor and retrieve publications for ICSR, PSUR, and DSUR reporting.
• Maintain documentation of search strategies and results for audits.
• Collaborate with PV scientists, medical writers, and regulatory teams to ensure timely reporting.
• Stay updated with GVP Module VI and global safety regulations.

Skills

Biomedical literature searching

Medical indexing systems

Boolean logic

Attention to detail

Multitasking

Written and verbal communication

Education

Master’s degree in Library Science or Information Management

Tools

EndNote

Mendeley

Job description

Role OverviewWe are seeking a detail-oriented and research-savvy librarian to support our pharmacovigilance team by conducting systematic literature searches to identify safety signals, adverse drug reactions (ADRs), and emerging safety information. This role is critical for ensuring compliance with global regulatory requirements and maintaining the safety profile of our products.Key ResponsibilitiesDesign 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.QualificationsMaster’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 SkillsExperience 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 .