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• Performed ICSR case processing in Argus 7.0 database triage, book-in, data entry, AE coding in MedDRA, narrative writing & peer reviews• Analyzed functional requirements, performed resource estimation to balance work volume & resources• Mentored new colleagues on case processing & adverse reporting activities as per company SOPs promoting a culture of high performance within the team• Participated in industry discussions for implementing new regulatory guidelines & provided inputs to QPPV, cluster lead in collaboration with the Country Safety Lead• Participated in global quality & compliance audits, provided the necessary data to the auditors & interacted with global teams to develop, implement & track audit CAPAs• Liaised with marketing, product leads, regulatory teams to manage adverse event reporting from business partners, CEP vendors as per the PV agreements• Gathered requirements, developed RFQs, performed vendor selection for outsourced activities• Conducted follow-up for all reported adverse events with physicians, customers, vendors of Customer Engagement Programs, business partners and clinical sites

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• Estimated impact of technology and business structure changes across 25 business functions • Conducted business continuity testing drills for 25 departments and documented lessons learned improving the incident response rate by 20% • Trained all departmental SPOCs on their respective business continuity management roles• Developed innovative business continuity management awareness initiatives at the corporate level• Participated as a certified observer with the lead auditor in conducting ISO 27001 information security audits• Scheduled and organized ISO 22301 certification audits for the organization meeting the certification requirements• Developed corrective and preventive action plans and implemented the audit observations to comply with the standard• Provided recommendations to business for enhancing the current business recovery and continuity strategies• Conducted periodic audit of departments to maintain the quality of the business continuity management practices• Developed and modified the risk profiles for every process in 25 departments to present high level risks to the management• Identified critical and non-critical processes for all departments to estimate key and back-up resources

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• Developed best practices for case processing activities and shared with local and global teams to improve team efficiency• Co-ordinated with the Product Quality team to handling product quality complaints and record events in ARGUS database as per company policies• Participated in global quality and compliance audits, interacted with global teams to develop, implement and track audit CAPAs• Maintained the departmental document repository on SharePoint enabling 100% compliance to company SOPs• Liaised with marketing, product leads, regulatory teams to manage adverse event reporting as per the PV agreements• Subject matter expert in adverse event coding using MedDRA dictionary, regulatory reporting and writing case narratives• Presented on in cluster meetings, assisted global team members exhibiting leadership on a global level

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• Planned cross-functional meetings, recorded and distributed meeting meetings to all involved stakeholders• Prepared project plans for global clinical trials, protocol amendments for investigational drugs• Co-ordinated with external stakeholders like Regulatory authorities for getting Test Licenses and Import Licenses

Master'S Degree, Project Management

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

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