GSK is seeking a Safety Evaluation Scientist-Literature to join our team in Bengaluru. This role involves performing pharmacovigilance (PV) literature surveillance, assessing safety data, and contributing to aggregate safety reports (such as DSURs, PBRERs) and risk management plans (RMPs).
Key Responsibilities:
- Screen and review literature search results (articles/abstracts/citations) for inclusion in aggregate reports and safety signal identification.
- Maintain up-to-date product knowledge for literature evaluation.
- Participate in quality improvement activities related to pharmacovigilance.
- Collaborate with SERM (Safety Evaluation and Risk Management) specialists and physicians to discuss safety findings.
- Analyze and interpret safety data, escalating potential risks as needed.
- Ensure compliance with global pharmacovigilance regulations and GSK standards.
Basic Qualifications:
- 3-6 years of experience in pharmacovigilance, drug safety, regulatory affairs, or medical affairs.
- Basic knowledge of post-marketing drug safety regulations.
- Understanding of causality assessment and safety signal evaluation.
- Experience in scientific literature review, data synthesis, and medical terminology.
- Familiarity with aggregate reports (DSURs, PBRERs), RMPs, and labeling documents (GDS, DCSI).
- Strong English communication skills (written & verbal).
- Proficiency in web-based applications and data analysis tools.
Why Join GSK?
GSK is a global biopharma leader committed to uniting science, technology, and talent to get ahead of disease. We focus on vaccines, specialty medicines, and innovative therapies in infectious diseases, HIV, respiratory/immunology, and oncology.
Our Culture & Values:
- Patient focus, Transparency, Respect, Integrity
- Courage, Accountability, Development, Teamwork
- Inclusive workplace with opportunities for growth
How to Apply?
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Interested candidates can apply before May 15, 2025.
