JOB DESCRIPTION:

Overall Purpose of the job

Responsible for activities for creating Aggregate Safety Reports to achieve the service level agreements. 

Responsibilities/ Authorities

Review, write and refine the draft of Aggregate Safety Report. 

Conduct analysis of single cases to determine the relevant section in aggregate reports

Create all documents in accordance to all applicable Standard Operating Procedures (SOPs), and conventions. 

Plan, organize, and manage daily work to meet service level timelines and deliverables. 

Work with the Aggregate Safety Reporting lead to escalate issues or tasks outside the normal scope of work. 

Attend a kick-off meeting and regular teleconferences with client partners during the preparation of Aggregate Reports;

Provide relevant client persons with draft line listings and/ or summary tabulations for new EU Aggregate Reports by the Day. 

After completion of the relevant sections and other requirements of Aggregate Reports, provide client with the initial draft of Aggregate Reports for scientific and medical review by the Day. 

Provide clients with the final draft of the sections of EU Aggregate Reports;

Provide client with a summary of the most frequent and most Serious Adverse Events, grouped per system organ class or Serious Adverse Experiences, grouped per body system, as specified per client Guidelines and SOPs;

Provide client with an overview of the Cases that resulted in death as specified per client Guidelines and SOPs. 

Promote/ participate, as appropriate, internal and external safety activities including regulatory audits

Mentor colleagues in area of expertise when assigned

Educational Requirements :

1. Degree in Healthcare Science Preferred, minimum requirement post graduate degree in life science . 

2. Background in clinical sciences is preferred. Minimum of 1 years experience in clinical domain. 

3. Min 

Salary: Not Disclosed by Recruiter

Industry            : IT-So        ftware / Software Services

Functional Area     : Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category       : Documentation/Medical Writing

Role                : Documentation/Medical Writing