Ashish Prakash

• Provide expert safety inputs to the clinical development program for assigned products and an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)
• Responsible for the development, regular review and update (as required) of key Safety documents of the organization
• Strategizing the Safety methodology and documentation of the same in the corresponding documents (e.g. Development Safety Profiling Plan - dSPP); Leading the preparation of the medical safety deliverables (e.g. DSUR, PBRER, RMP) for the assigned products
• Responsible for the overall Signal management process of the assigned products including monitoring, detection, validation, evaluation, interpretation and appropriate communication of new safety information, and effectively collaborating with various stakeholders (Pre-clinical/ Clinical/ Regulatory/ Epidemiology); Chair the Safety Management Team (SMT) meetings (regular/ adhoc)
• Providing responses to inquiries from Regulatory Authorities or Health Care Professionals on safety issues; Lead the preparation of the safety strategy for Health Authority (HA) responses, in collaboration with various cross-functional stakeholders
• Represents safety at HA meetings in context of New dug Application (NDA) submission activities
• Responsible to provide expert medical inputs to committees, like trial/ project level Drug Safety Monitoring Board/ Data Monitoring Committee and Safety Adjudication Committee for assigned projects
• Ensure compliance with all applicable laws, regulations and standards as per global pharmacovigilance (PV) guidelines
• Lead the regular safety activities and provide guidance to junior personnel in th edepartment
• Proactively engage in the development of competency across the Medical Safety Function
• Currently, operational manager of six safety leads.
• Assist with training and mentoring of new safety leads
• Provided guidance and support for team members in order to enhance their work performance and development.
• Conduct regular meetings with the team members/ cross-functional stakeholders to discuss progress on projects and tasks.

• Project management
• Vendor Management (outsourcing strategy - RFP discussions, strategy on metrics to measure KPIs)
• PV Quality and Compliance Deviation management
• PV Operations Responsible person maintaining an oversight over all global vendors, thus ensuring quality and compliance
• POC (Point of Contact) for Audits and Inspections representing Medical function team from Safety
• Lead for all merger and acquisitions as a stakeholder of Medical Safety

• Defined the entire safety process in alignment with EMA requirements for case processing of ICSRs (Individual Case Safety Report)
• Responsible person for the medical review of all ICSRs and PBRERs
• Posted as the Deputy National Safety Officer for India region.

• Responsible for Medical review of ICSRs/ Literature articles/ Expert Safety inputs for aggregate reports
• Responsible person for interaction with patients and physicians for the purpose of identification of valid ICSRs reported to call centers

• Responsible to take care of all patients in the indoor department of the hospital.

Worked as a casualty medical officer, responsible for initial work-up, history taking, primary health care and effective triaging of patients.