Gbu Icsr Medical Oversight

**Major duties and responsibilities as per SMP**: Oversees the Medical Review (MR) of ICSRs as per predefined activity and job-role in PV safety database, with special focus on case medical accuracy and documentation, - Maintains overall accountability for the timeliness and quality of medical case management activities outsourced to service providers, -...

Major duties and responsibilities: Submission Reviewer is a centralized role that: - Has oversight of the reporting rules configuration for compounds, marketed drugs, devices, and vaccines to ensure proper distribution / submission to health authorities, affiliate countries, license partners / collaboration partners. - Has regulatory reporting expertise in...

Major duties and responsibilities: - oversees the Medical Review (MR) of ICSRs as per predefined activity and job-role in PV safety database, with special focus on case medical accuracy and documentation, - maintains overall accountability for the timeliness and quality of medical case management activities outsourced to service providers, - leads or...

We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety. **Responsibilities**: Clinical Phase: - Lead as a medical monitor/Medical expert - Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as...

We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety.Responsibilities:Clinical Phase:Lead as a medical monitor/Medical expertMedical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required and...

**Job ID** R0000031576 **Category** Medical Sciences **ABOUT THIS ROLE**: **Job Purpose**: - The Drug Safety Associate II, will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures...

We are looking for a Team lead/ Manager/ senior medical advisor/reviewer proficient in all aspects of clinical and post-marketing drug safety. Responsibilities: Clinical Phase: Lead as a medical monitor/Medical expert Medical Monitoring experience is a must and the ability to effectively communicate with the clients, attend investigator meetings as required...

Provide oversight and support to vendors to ensure productivity and quality of all activities - Maintain technical and global regulatory expertise - Ensure adequacy of training on different topics: Database, SOP, and knowledge in pharmacovigilance field, library and clinical development in order to improve flexibility, professionalism of all resources -...

The Senior Clinical Data Coder is primarily responsible for leading and overseeing activities related to the coding of clinical data across multiple ongoing studies. In addition to performing accurate coding tasks, the Senior Coder takes ownership of the coding module setup, establishes conventions, and drives the prioritization of coding deliverables. This...

**Description** **Principal Clinical Programmer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...