Darshana Muni Email & Phone Number

Boston, Massachusetts, United States

United States

• Reviewed and modified facility documents for an API manufacturing facility construction project
• Implemented process improvements for document reviews to significantly reduce the review time per document
• Refined metadata for facility documents in QulaityDocs ensuring 100% compliance to the Facility Documentation SOP

Mumbai Area, India

• Performed operational pharmacovigilance activities for clinical trials, marketed products & patient support programs
• Managed external stakeholders ensuring 100% monthly compliance for SUSAR & SAE Regulatory Authority reporting for 5 countries
• Developed reporting schedules, revised aggregate reporting process for PBRERs, DSURs in collaboration with Regulatory team, Quality & Compliance team
• Revised company SOPs and work instructions to ensure compliance with regulatory requirements & company quality standards
• Completed monthly quality reviews of Customer Engagement Programs, reviewed vendor AE reporting processes to identify gaps, develop & implement CAPAs
• Performed daily, monthly reconciliation activities with vendors, business partners & clinical sites ensuring appropriate safety data exchange as per company standards

Mumbai Area, India

• Worked as an assistant project manager for the implementation of ISO 22301 BCMS standard within the organization
• Developed the project charter, defining project objectives, developing a rationale and participating in gap analysis audit
• Identified risks, estimated the severity and probability of occurrence to develop a comprehensive risk management plan
• Modified SOPs for 25 department to meet the ISO22301 BCMS requirements
• Conducted Threat Analysis and Business Impact Analysis (BIA) to determine critical business processes and to identify acceptable disaster recovery times
• Established resource requirements for successfully resuming the critical business operations in the event of a disaster

Mumbai Area, India

• Ensured 100% monthly compliance to regulatory timelines for SUSAR and SAE Regulatory Authority reporting
• Acted as an ICSR workflow manager, monitored the central AE mailbox, prioritized the incoming cases appropriately in the daily workflow
• Supported revision of functional processes to modify the company SOPs and work instructions
• Led case processing in Argus 7.0.7 database for 33 Pfizer products in compliance with company standards
• Managed follow-up communications with business partners; physicians and regulatory agencies
• Analyzed functional requirements mapping them to organization goals to facilitate resource allocation

Mumbai Area, India

• Managed ICSR and aggregate report submissions for all marketed products according to Regulatory Authority requirements
• Performed case triage and managed the open action items for daily adverse event reporting activities
• Participated in safety audits, developed corrective and preventive action plans for audit observations
• Co-ordinated with internal stakeholders like product quality to handle product technical complaints
• Maintained training records for the entire department according to the Corporate Compliance policies in SharePoint
• Scheduled cross-functional meetings, recorded and distributed meeting minutes and tracked open action items

Master'S Degree, Project Management

Master Of Science - Ms, Clinical Research And Regulatory Affairs, Distinction

Bachelor Of Science (B.Sc.), Microbiology, General, Merit