PUNE · FULLTIME
Librarian
Fortrea Development India Private Limited
Pune · onsite · Posted 12d ago
Sourced from
Undisclosed2–7 yrsfulltimePune
Your match
?
Sign in to see your match score, skill gaps & tailored resume.
Section · 01
About this role
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 .
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Let the agent run this one for you.
Tailored resume, auto-apply, and referral lookup — in under 2 minutes.
Section · 02
Skills
Indexinganalytical thinkingLibrary Sciencegvppharmacovigilanceinformation managementPVBiomedicalDrug safetyRegulatory Affairsauditsliterature searchHealthcareCommunication SkillsLiteraturecompliancePharmaceutical
Section · Company
About Fortrea Development India Private Limited
Fortrea Development India Private Limited
Clinical Research
3.2k+
employees
2023
3 years old
Bangalore / Bengaluru, Karnataka
India
₹6.8L PA avg
Avg at Fortrea Development India Private Limited
About
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and technology solutions across more than 20 therapeutic areas to the life sciences industry.
Industries
Clinical ResearchBiotech & Life sciencesAnalytics & KPO
Employee ratings
10 reviews
3.9/ 5
Culture
4.0
Career growth
3.4
Work-life
4.3
Employees rate it well for
Company Culture39Work-Life Balance39
Find them on