Sameer Adawade Email & Phone Number

Mumbai, Maharashtra, India

· Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader· Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process· Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management· Contributes to achieving company´s goals and objectives· Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing… Show more · Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader· Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process· Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management· Contributes to achieving company´s goals and objectives· Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency) Show less

Mumbai, Maharashtra, India

1. Coordination and management of case processing for assigned pharmacovigilance (PV) cases2. To deliver relevant training to the team as per the requirement of the project3. To coordinate the workload and manage staff as per the workload on a project4. To be a one point contact for the client and managers5. Ensure effective training and certification of the team for processing PV cases6. To be aware and make team members aware of client standards and SOPs7. To ensure… Show more 1. Coordination and management of case processing for assigned pharmacovigilance (PV) cases2. To deliver relevant training to the team as per the requirement of the project3. To coordinate the workload and manage staff as per the workload on a project4. To be a one point contact for the client and managers5. Ensure effective training and certification of the team for processing PV cases6. To be aware and make team members aware of client standards and SOPs7. To ensure that the timelines of all the deliverables are met, keeping quality as a priority8. Providing metrics as per the request of the client staff or management9. Motivate team, to deliver quality work and believe in team spirit10. To communicate with team members and resolve or escalate their queries11. To address any concerns of client staff or management12. To track the progress of the cases with respect to time and quality13. Attend regular teleconference with the client and communicate and address any project related issues or concerns14. To be prepared for client audits and prepare the team members for the same15. Proactively identify and implement opportunities for process improvement and takes accountability for implementing the same Show less

• Team lead of case processing team of size 20 associates.• Workflow manager for influx and daily production• Compliance management: Regulatory, submission compliance and Training compliance• RCA CAPA management: End to end handling, assigning RCA CAPA, following up with teamfor closure of CAPA in timeline, maintaining tracker for deviations, evaluating implementationof CAPA with documentation.• Induction to sign off assistance to new joiners.• Leave planner.•… Show more • Team lead of case processing team of size 20 associates.• Workflow manager for influx and daily production• Compliance management: Regulatory, submission compliance and Training compliance• RCA CAPA management: End to end handling, assigning RCA CAPA, following up with teamfor closure of CAPA in timeline, maintaining tracker for deviations, evaluating implementationof CAPA with documentation.• Induction to sign off assistance to new joiners.• Leave planner.• Periodic submission to USFDA• USFDA, PvPI CDSCO, TGA, Russia, Canada submission• Faced FDA MHRA Health Canada and client audits Show less

Andheri East

• Implement consistent, efficient, and quality process to meet timelines and deliverables according to requirements and standard operating procedures.• Ensure compliance of operations with governing regulatory requirements• Create, maintain, and assume accountability for a culture of high customer service.• Assume responsibility for quality of data processed.• Performed Case Processing (Pharmacovigilance) starting from triage, data entry, writing safetynarratives, performs… Show more • Implement consistent, efficient, and quality process to meet timelines and deliverables according to requirements and standard operating procedures.• Ensure compliance of operations with governing regulatory requirements• Create, maintain, and assume accountability for a culture of high customer service.• Assume responsibility for quality of data processed.• Performed Case Processing (Pharmacovigilance) starting from triage, data entry, writing safetynarratives, performs follow ups, etc. Triage the case when required. Medical coding with thehelp of MEDRA, Literature sheet review and generation of action items• Social media monitoring (identification of client specific sites and products and related ADR’s).• Argus database 8.0 configurations and UAT script running.• Managing change request forms (start to end process)• Literature search and case processing from Eudravigilance and Embase. Show less

Airoli

• Performing the proper duplicate check, creating ICSRs and booking the cases.• Processing of ICSRs based on regulatory timelines and submission and narrative writing.• Quality checks all the ICSRs routing from data entry workflow to medical review workflow.

Bachelor'S Degree Of Pharmacy, Pharmacy And Clinical Data Management, First Class

Activities and Societies: debate, quiz....

H.S.C, 78%

S.S.C, 83%