JOB DETAILS

1) Lead preparation of global periodic safety reports for newly launched products. Lead coordination with GLFs to ensure information received, analyzed and incorporated into ARs as per the regulatory requirements. 
2) Independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Hospital standards 

3) Support in creating strategy for data analyses and presentation in global periodic safety reports. Support in addressing the Health Authority (HA) comments adequately in PSURs. 

4) Support in the development of safety document templates and Standard Operating Procedures pertaining safety aggregate reports 

5) Contribute to global projects focusing on process & quality improvement initiatives.

6) Support Head, Safety Report Writing/Head, Aggregate reports and assist with the recruitment of new staff.
FUNCTIONAL AREA
Medical writer, Medical ...