Librarian

FTINDSCISEZ1 Fortrea Scientific Private Limited SEZ1; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

Fortrea is seeking a detail-oriented librarian to support pharmacovigilance by conducting structured literature searches to identify safety signals, ADRs, and emerging safety information. You will design search strategies across major databases and maintain documentation for audits.

Role requires a master's in library science, 2+ years in biomedical searching, and familiarity with MeSH/Emtree indexing, Boolean logic, and PV regulations (EMA, FDA, ICH).

Qualifications

• Master's degree in Library Science, Information Management, or related field.
• At least 2 years of biomedical literature searching experience.
• Familiar with MeSH and Emtree indexing and Boolean logic.
• Understanding of pharmacovigilance principles and regulatory frameworks (EMA, FDA, ICH).

Responsibilities

• Design and execute literature search strategies using PubMed, Embase, Scopus, and Web of Science.
• Monitor and retrieve publications for ICSRs, PSURs, and DSURs.
• Document search strategies and rationale for regulatory audits and inspections.
• Collaborate with PV scientists, medical writers, and regulatory teams for timely reporting.
• Stay current with GVP Module VI and other global safety regulations.

Skills

Literature searching

MeSH indexing

Boolean logic

Pharmacovigilance

Regulatory knowledge

Communication

Education

Master's in Library Science

Tools

EndNote

Mendeley

Job description

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.

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day.