Job Description
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.
Key responsibilities
Provide comprehensive safety services across the lifecycle of pharmaceutical compounds and medical devices, from first in human clinical trials through post-approval, marketed product, and regulatory safety requirements. Collect, track, and report adverse events or clinical outcomes; analyse and report aggregate safety data; perform safety surveillance; and perform benefit-risk evaluation and planning.
Provide data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities. Triage, track, and process saf...