Fortrea is hiring a Medical Librarian for its Pharmacovigilance team in Pune, Maharashtra. The role focuses on systematic biomedical literature searches to identify safety signals, adverse drug reactions (ADRs), and emerging safety information while supporting regulatory compliance and product safety.
Job Details
| Particular | Details |
|---|---|
| Company | Fortrea |
| Position | Medical Librarian |
| Location | Pune, Maharashtra |
| Employment Type | Full Time |
| Job Requisition ID | 265735 |
| Experience | Minimum 2 years |
| Posted | Today |
Role Overview
The Medical Librarian will support pharmacovigilance activities by designing and conducting systematic literature searches and identifying relevant safety information. The position also involves maintaining search documentation and collaborating with pharmacovigilance, medical writing, and regulatory affairs teams.
Responsibilities
- Design and execute comprehensive literature search strategies using 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.
- Stay current with Good Pharmacovigilance Practices (GVP), particularly Module VI, and other global safety regulations.
Eligibility & Qualifications
- Master’s degree in Library Science, Information Management, or a related field.
- Minimum 2 years of experience in biomedical literature searching, preferably within a pharmaceutical or healthcare setting.
- Familiarity with medical indexing systems such as MeSH and Emtree.
- Knowledge of Boolean logic.
- Understanding of pharmacovigilance principles and regulatory frameworks including EMA, FDA, and ICH.
- Strong attention to detail.
- Ability to manage multiple priorities under tight deadlines.
Preferred Skills
- Experience with reference management tools such as EndNote and Mendeley.
- Knowledge of drug safety databases and signal detection methodologies.
- Certification in pharmacovigilance or drug safety, such as DIA or PV training programs, is a plus.
- Strong analytical skills for evaluating complex medical information and identifying relevant safety data.
- Excellent written and verbal communication skills for interaction with internal teams, regulators, and medical professionals.
Key Skills
- Biomedical Literature Searching
- Pharmacovigilance
- Systematic Literature Searches
- Medical Indexing
- MeSH & Emtree
- Boolean Logic
- Drug Safety
- Signal Detection
- Regulatory Compliance
- Medical Research
- Scientific Communication
- Reference Management
Application Details
