Senior Drug Safety Specialist, Senior Drug Safety Associate, Data analyst

* Provided dedicated support on Medical Information/Drug Safety aspects of the ICSR and Literature case process and collaborated with
other functional areas of the organisation. Maintains, understanding and compliance with SOPs, Work Instructions (WIs), global
drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.
* Resolved preventable issues with drug safety database by working with IT Department, which decreased the audit time by 40%.
Reduced safety profile writing time by 33% by standardising the process.
* Gather, review, analyse, and evaluate pertinent resources to prepare, develop, and finalize low complexity documents, such as patient
narratives, public disclosure documents, and aggregate safety reports (e.g., Periodic Adverse Drug Experience Report [PADERs]), under
supervision of the project medical writer or other appropriate departmental supervision.
* Provided pharmacovigilance data analysis, authoring, and quality control (QC) expertise for the preparation of a range of global regulatory
aggregate safety reports, including PADER, DSUR, PSUR/PBRER, etc.
* Participated in writing of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as
appropriate
* Authoring and review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for
submission to local and other Health Authorities
* Collaborated with international affiliates to ensure accuracy and completion of drug safety reports.
* Managed daily workload for signal, literature searches, aggregate reports generation and any other tasks relevant to the
Pharmacovigilance Department.
* Developed, maintained and updated safety-related documents for regulatory submissions, Sop's and Risk Management Plans.
* Established continuous processes and procedures to ensure compliance with applicable regulations and client standards.
Successfully analysed and reported on safety data for adverse event trends and safety signals.
* Managed a process re-engineering project to improve and consolidate end-to-end service processes; restructured communication flow
among
* Training and mentoring of new employees in pharmacovigilance team.
* Provides mentoring and work direction to more junior level staff.
* Analyses, reviews, and interprets safety data, both non-clinical and clinical and any other relevant sources

* Managed processing of individual case safety reports (ICSR), spontaneously as well as from business partners.
* Managed a process of End-to-End Processing of the case.
* Review of adverse events case reports of regulatory reporting.
* Effectively communicates with managers, project team members, and client contacts
* Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in
processes.
* Provide administrative support for the preparation of safety writing deliverables for both developmental and market-authorised
products.
* Training and mentoring of Pharmacovigilance associates
* Creation/Maintenance of periodic safety report (aggregate reporting in Pharmacovigilance) timetable/calendars.
* Classification of aggregate reports.
* Tracking and managing the preparation of reports based on pharmacovigilance aggregate reporting period and database lock.

* Skilled in health care information entry into database quality and tracking systems for receipt and tracking patient reports.
* Assisted in the processing of cases according to Standard Operating Procedures (SOPs) and project/program-specific safety
plans.
* Triaged safety reports, evaluated data for completeness, accuracy, and regulatory report ability.
* Data Entry into safety database like Argus, Airs'G. Coding events, medical history, concomitant medications and tests.