•Ensure that collection, reporting and handling of safety information associated with Company products is performed according to global and local regulatory requirements.•Develop local Risk Management Plans (RMP) and ensure oversight of RMP implementation, including adequate documentation of risk minimization activities, materials, decisions, and actions taken.•Ensure that safety queries and safety issues are managed effectively and in a timely manner.•Ensure appropriate safety reporting and oversight processes are in place for Market Research and Patient Support Programs (MAPs), pre-approval and post-trial access programs (including compassionate use program).•Ensure that relevant information is provided to global functions for the preparation of aggregate reports Additional Responsibility: + Local coordinator compassionate use program of Risdiplam:•Maintains contacts with the requesting physician, treating site.•Serves as point of contact for the HCPs for program related requests.•Builds and maintains a strong relationship with the global team and with the local PAIRS coordinator network.•Tracks and documents requests using PAIRS.Project:+Backup Local Quality Responsible (Jan 2022 - Apr 2022)•Assist and support LQR for proactively ensuring that all GCP /GVP governed activities are delivered to the Roche standard of quality and drives compliance in accordance with the applicable regulatory requirements, the Roche QMS, Policies and written procedures and industry best practices.•Assist and support LQR in the Risk Management Process for Medical Compliance at local level •Assist and support LQR in driving and enabling the overall CAPA Management process at local level•Assist and support LQR in the implementation of global processes and process improvement initiatives in their affiliate•Assist and support LQR in ensuring the consistent alignment between local and global procedural documents

-Assisted country study manager in completing the post study close out activities which includes TMFmanagement and closeout, oversight on CRO, deviation and CAPA management.

•TDM, DUR of selected antibiotics, renal adjustment and hepatic adjustment of drugs.•Patient Profile Review, Laboratory Interpretations.•Avoiding unnecessary drugs, lab tests and duplication.•Drug-drug, drug-disease, drug-food interaction screening.•Calculations of dose reduction of chemotherapeutic drugs.•Aseptic Handling of Chemotherapeutic drugs.•Preparation of TPNs, injectable chemotherapy and other IV therapy.•Patient Counselling about drug use, indication, interactions, contraindications, storage.•Management of ER pharmacy; critically reviewing orders.•Handling of poison calls from various parts of the city.•Provision of accurate information utilizing relevant references to hospital staff and patients.•Compounding of different preparations.•Maintained Pharmacy Areas as per ISO and JCIA standards.•Assisted pharmacist in expiry and inventory management activities.