ALAY SINGHAL

1) Risk Management Team (RMP) team

• Involved in Medical review, identifying safety concerns and preparing RMP for Europe based clients / REMS for U.S clients.
• Medical review of Effectiveness assessment report and aggregate reports.
• Preparation and review of routine and additional risk minimization measures and PV activities including effectiveness of ARMMs as required and communicating the same to the relevant internal and external stakeholders.
• Medical support for Risk Minimization Measures development.

2) OTSUKA Team

• Aggregate reports authoring & medical assessment and supporting signal management operations
• Accountable for Signaling data review, assessment
• Contribute Medical Assessment for Aggregate Reports and HA responses for safety-related topics.
• Contribute to content and participate in safety governance meetings (SMT, JSMT)
• RMP authoring ownership. Collaboration with Safety Scientist, Medical Affairs and Regulatory counterparts on implementation and risk minimization measures
• Train and mentor new medical reviewers in pharmacovigilance.

• Participated in the Pharmacovigilance Programme of India by way of collection, analysis and reporting of adverse drug reactions to the National Coordinating Centre, conducted Clinical pharmacology exercises (preparation of protocol of clinical trials, informed consent form and case-based learning from actual clinical cases),teaching pharmacology as subject to undergraduate students.

• Worked as INVESTIGATOR conducting BA/BE studies, Protocol Review and feasibility assessment, handling and documenting ADVERSE EVENTS/ SAEs, attending IEC/IRB meetings, consent taking with Audio Visual Recording at Veeda Clinical research, Ahmedabad.

Handling emergencies, conducting OPDs , handling medicolegal cases at COMMUNITY HEALTH CENTER

• Handling Emergencies in the Neuro ICU department.
• Treatment/ maintenance of ward patients.
• Documenting History/ Discharge summaries of patients.