Librarian

Fortrea; Maharashtra; Sur place; INR 800 000 - 1 200 000; Plein temps

Résumé du poste

Fortrea in Maharashtra, India seeks a detail-oriented librarian to support pharmacovigilance by conducting systematic literature searches to identify safety signals, ADRs, and emerging safety information, ensuring regulatory compliance.

The role collaborates with PV scientists, medical writers, and regulatory affairs, uses databases like PubMed, Embase, Scopus, and Web of Science, and stays current with GVP Module VI and 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.

Responsabilités

• Design and execute comprehensive literature search strategies using databases such as PubMed, Embase, Scopus, and Web of Science.
• Monitor and retrieve relevant publications for ICSR, PSUR, and DSUR.
• 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.

Connaissances

Biomedical literature searching

Boolean logic

MeSH/Emtree knowledge

Attention to detail

Communication

Formation

Master’s degree in Library Science or Information Management

Outils

EndNote

Mendeley

Description du poste

Role Overview

We 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 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.