Job Description- Drug Safety Physician 1. Collaborates with, medical monitors and other functional groups in identification, analysis, and reporting of possible safety related trends or concerns. 2. Contributes to development & maintenance of product safety profile. 3. Supports and/or drafts regulatory query responses related to pharmacovigilance / safety issues to regulatory agencies, EC/IRB, Investigators and adhoc enquiries. 4. Provides input and review for key regulatory or clinical documents (i.e. protocols, clinical study reports, investigator brochures, integrated summaries of safety, DSUR, etc.) related to pharmacovigilance. 5. Performs follow-up on pending Corrective and Preventive Actions (CAPAs) and ensures implementation of the same in the Global compliance database. 6. Performs compliance data analysis using available tools to identify potential trends. 7. Performs literature search and review and able to effectively determine appropriate and relevant literature for the purposes of safety analysis. 8. Supports the conduct of pharmacovigilance audits/regulatory inspections. 9. Participates in internal pharmacovigilance committee meetings as well as joint safety meetings with partners. 10. Prepare and/or review regulatory Pharmacovigilance reports e.g., expedited, periodic, aggregate, RMP 11. Ensures timely reporting of safety reports to regulatory agencies and to business partners as per the SDEA. 12. Performs medical Reviews of ICSRs obtained from various sources e.g. spontaneous reports, literature reports, solicited reports, regulatory authority reports, SAEs from clinical trials. 13. Prepares, reviews and evaluates PSURs, DSURs and review of CER. 14. Prepares and maintains various regulatory PV documents including Risk Management Plan (RMP), DDPS, PSMF, SDEAs etc. 5. Periodically reviews safety data for potential signals – part of signal detection team. 16. Ensures regulatory compliance vis-a-vis global Pharmacovigilance regulations. 17. Prepares and maintains SOPs, working guidance and ensures their implementation. 18. Prepares and/or reviews safety sections in clinical study protocols and clinical study reports. 19. Prepares and/or reviews safety management plans for clinical trials. 20. Reviews and analyzes SAE reports from clinical trials. 21. Ensures reconciliation of clinical trial SAEs in safety database with clinical database. 22. Ensures tracking of events of special interest and assists in development and maintenance of standardized queries for events of special interest. 23. Trains and mentors the team members
Job Title
drug safety physician