Viewing a Biotechnology Job / Pharmaceutical Job:   Sr Manager of Drug Safety

Partial Job Description 1) Ensure medical, regulatory, and logistics management of the Serious Adverse Events (SAE) that occur in the company trials 2) Manage the SAE reports from a medical, regulatory and administrative standpoint 3) Review SAEs in the Safety Database (AERS), including event narratives 4) Code AEs and SAEs in the clinical database and AERS 5) Review the SAEs for administrative and medical consistency, including requesting follow up and clarification information from the investigator 6) Submit SAE reports to the relevant parties 7) Set up, implement and maintain efficient SAE processing/dispatching logistics for the investigators, CRAs, sponsors and health authorities 8) Provide support to the project managers (global clinical coordinators and study managers) and the CRAs to ensure an appropriate monitoring and follow up of the SAE 9) Implement and maintain an efficient collaboration and communication process with the PV departments of the sponsors 10) Write the pharmacovigilance report requested by the IDMC/DSMB 11) Contribute to the training of the members of a study team (including CRA, study coordinators, investigators) involved in the clinical research as far as safety and pharmacovigilance are concerned 12) Contribute to the writing of SOPs, guidelines and processes 13) Perform other safety and pharmacovigilance duties as required