Deepali Mahesh Sangamnerkar

Regulatory Intelligence & Compliance

• Create and maintain repository of and communicate on international and national legislations and guidelines related to pharmacovigilance for all range of product.
• Identify and address potential regulatory issue that may have an impact on the current pharmacovigilance procedure and strategies.
• Research, analyze and extrapolate critical regulatory information with focus on pharmacovigilance requirements.

ICSR Submission Management

• ICSR Submission activities to different geographics via electronic and manual mode within agreed timelines with adherence to regulatory guidelines and applicable standards
• Ensure adherence to regulatory timelines and standards.

Team Leadership

• To work with team considering client commitment, expectation, Ad Hoc demands and ensure that project is deliverables within agreed timeline with good quality.
• To identify risk areas, ongoing issues in the project and mitigate them beforehand.
• Coordinate with team to ensure smooth delivery of the deliverables.
• Closure of CAPA before due date with approval from all respective stakeholders.
• To lead weekly client meeting. To share Agenda before call and MOM (Minutes of meeting) after meeting with all the invitees.
• To lead weekly and monthly internal meeting with higher management and give update on overall project progress.
• Identify quality problem, if any and bring them to the attention of project manager.
• To ensure that project is Audit ready anytime. To publish audit readiness scores with higher management.
• Monthly incoming and outgoing case reconciliation with multiple domains.
• Leave management. New hire request and interview candidates for the respective roles.

Case Intake & Processing

• Intake and case processing of ICSRs received from local safety database and global safety database as applicable according to SOPs, user manual and relevant data entry instructions.