Clinical Safety Scientist

**Job Description**: The Clinical Safety Scientist (CSS) is responsible for support of safety reporting in clinical trials conducted in multiple therapeutic areas as part of investigational product development programs across early and late stage development. **Key responsibilities**: - Intake of reportable safety event information from clinical trial...

**The Position** - High performing senior specialist who leads signal detection, safety evaluation and risk management planning and activities for key Organon’s _highly complex_ medicinal products and/or medical devices during clinical development and/or for post-marketing PV setting from a scientific perspective by active participation and contribution...

The Medical Writing Department of the GCTO organization prepares various regulated documentation. The Senior Medical Writer Safety Services role focuses on participant safety reporting, such as participant narratives, that support the clinical and regulatory writing portfolio. The Senior Medical Writer Safety Services is responsible for developing and...

**Job Description**: The Director provides dynamic leadership and strategic direction with regards to high quality and excellent compliance of individual case safety reports (ICSRs) and, the performance and results of the Medical Safety Review (MSR) Physicians in the US and globally. This role has responsibilities for ensuring operational and scientific...

As a Drug Safety Associate you will be joining the world’ s largest & most comprehensive clinical research organization, powered by healthcare intelligence. **What you will be doing**: A Drug Safety Associate is a professional who is an integral part of drug development lifecycles to collect accurate safety information and to ensure patient safety.-...

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...

**Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and...

**Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the Clinical Research Associate manager the person ensures compliance of study conduct with International Conference on Harmonisation Good Clinical Practice and country regulations, our company policies and...

Must have a Bachelor's Degree (or equivalent) with 4 - 6 years of relevant healthcare experience including 2 - 3 years of monitoring & site management experience. - All aspects of site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical investigator sites within the approved Clinical Development Plan (COP). These...

Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is...