Vaibhavi Mestry

• Leading a team of 20 Associates for project management, client management along with resource management.

• Ensuring regulatory compliance vis-a vis global pharmacovigilance regulations.

• Reviewing the operational practices, identifying the areas of quality failures and advising on system and process changes for quality improvement

• Collaborate with associates during planning meetings regarding project timelines, and project-related issues focusing on capabilities within, but not limited to, Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management.

• Investigating deviations, change controls, incident reports, OOT & OOS results to take remedial measures as per QC norms and providing appropriate CAPA

• Collaborating with different functional team members, e.g. project management, clinical, data management, healthcare professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.

• Reviewing the operational practices, identifying the areas of quality failures and advising on system and process changes for quality improvement.

• Participate in improvement projects as defined by the relevant process improvement management team. Conduct project lesson learn sessions and create a recommendations report in order to identify successful and unsuccessful project elements, when applicable.

• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

• Prepare and present study-specific materials and services at Investigator, Kick-off meetings. Participate in external and internal audits as required.

• Executed the study protocol, study guidance documents and transcript .
• Performed accurate data capture for individual case safety reports.
• Worked as Quality checker for various case types.
• Submitted SUSAR cases for clinical trial studies and studied unbinding, code not broken sheet, RSI, IB, USPI, EURSI
• Shared MedDRA requests as needed and discussed the same with Operation Physician Team regarding the amendment/ split and raising of queries regarding the events.
• Conducted triage of regulatory submission and narrative writing as per regulatory format
• Performed tasks in quality review process and case allocation process.
• Aligned the process lifecycle safety data according to applicable regulations, guidelines and Standard Operating Procedures (SOPs).

• Performed accurate data capture for individual case safety reports Executed the study protocol, study guidance documents and transcript
• Processed different types of case types such as Spontaneous, Regulatory authority etc.
• Submitted SUSAR cases for clinical trial studies • Studied unbinding, code not broken sheet, RSI, IB, USPI, EURSI
• Shared MEDdra requests as needed and discussed the same with Operation Physician Team regarding the amendment/ split and raising of queries regarding the events.
• Completing narrative writing as per regulatory format.
• Worked in triage of regulatory submission.
• Aligned the process lifecycle safety data according to applicable regulations, guidelines and Standard Operating Procedures (SOPs).

• Performed accurate data capture for individual case safety reports Executed the study protocol, study guidance documents and transcript
• Processed different types of case types such as Spontaneous, Regulatory authority etc.
• Submitted SUSAR cases for clinical trial studies • Studied unbinding, code not broken sheet, RSI, IB, USPI, EURSI
• Shared MEDdra requests as needed and discussed the same with Operation Physician Team regarding the amendment/ split and raising of queries regarding the events.
• Completing narrative writing as per regulatory format.
• Worked in triage of regulatory submission.
• Aligned the process lifecycle safety data according to applicable regulations, guidelines and Standard Operating Procedures (SOPs).