Argus, 12CFR, E2B,VEVVA,POWERBI,SQL
Anuradha Nagdevte
Team Manager
Mumbai
Summary
Adept at process and report analysis, I significantly enhanced operational efficiency at Tata Consultancy Services through meticulous quality assurance and innovative problem-solving. My expertise in eCTD software and ability to mentor for leadership readiness underscore my dual strengths in technical proficiency and team development.
Overview
11
11
years of professional experience
91
91
years of post-secondary education
Work History
Process Associate
Tata Consultancy Services
02.2016 - Current
- Managed multiple tasks simultaneously, ensuring timely completion of all assignments.
- Communicated effectively with colleagues and supervisors to resolve issues promptly and accurately.
- Participated in regular team meetings, contributing valuable insights toward process enhancements.
- Handled high volumes of incoming work requests professionally while maintaining excellent organization.
- To perform individual case safety report(ICSR) as E2B(R3) requirement. Assessment of case reports for seriousness, causality, and expectedness. Assess labelling as per requirement and additional drug safety specialist activities as required.
- Effectively maintain safety database and corresponding entry guidlines, including accurate entry of data and assurance of quality of data through quality control process.
- Perform consistent coding of adverse event, special events and medications according to the project specific convections.
- Review clinical trail protocol and provide inputs, support processing of data. Generate concise, accurate and well-written case narrative.
- Performed case processing of spontaneous, study, non-blinded, PQS case, Device and Literature Cases. Worked with Trainers to develop presentation on Root Cause Analysis(RCA) and robust Corrective and preventative Actions.
- Seamlessly integrating those learnings into training sessions for enhanced understanding and implementation.
- Maintained continuous communication with team leads, sharing quality metric update and identifying non-conformity trends and operational gaps.
- Took the refresher session to reduce the convectional gaps in process. Escalate functional and conceptual trainings gaps.
- Tailored the role of reviewer to address recurring issues and stimulate ongoing refinement of practices, thereby cultivating a culture of continual compliance enhancement.
- Collaborated with team members for enhanced process efficiency and productivity.
- Maintained high levels of data confidentiality through adherence to company policies and procedures.
- Monitored and reported on process performance to verify compliance with established standards.
- Adhered to all deadlines, managing time effectively to complete tasks within designated timeframes.
- Provided exceptional customer service when interacting with clients or vendors during process execution tasks.
- Supported management in analyzing process performance data, identifying areas for improvement.
- Developed strong working relationships with cross-functional teams for seamless collaboration on projects.
- Increased processing speed by mastering software tools and utilizing keyboard shortcuts efficiently.
- Identified and resolved process issues to drive optimal workflow and business growth.
- Assisted in the development of training materials for new hires, improving onboarding experience and knowledge retention.
- Prioritized initiatives to increase success rates of strategic projects.
- Independent problem solver who took initiative in researching solutions without needing excessive supervision.
- Managed critical projects from inception to completion, ensuring that all objectives were met on time and within budget.
- Increased accuracy in data processing by conducting regular quality checks and implementing corrective measures when necessary.
- Fostered positive and collaborative work environment, contributing to high team morale and low turnover rates.
- Improved client satisfaction with timely and accurate processing of requests and inquiries.
- Negotiated with vendors for better terms, resulting in cost savings and improved service quality for company.
- Reduced processing times for key tasks, enabling team to handle higher volumes without compromising quality.
- Achieved substantial cost savings by optimizing resource allocation and minimizing waste.
- Conducted thorough analysis of existing processes, identifying key areas for improvement and efficiency gains.
- Facilitated cross-departmental collaboration, leading to more cohesive and efficient project completion.
- Proactively identified bottlenecks in process flow, implementing effective solutions to eliminate delays.
- Implemented new software tools to automate repetitive tasks, freeing up valuable time for more strategic activities.
- Streamlined processing procedures, significantly reducing errors and improving overall workflow efficiency.
- Acted as primary point of contact for client escalations, resolving issues swiftly to maintain high levels of client satisfaction.
- Trained new team members on best practices and company-specific procedures, enhancing overall team performance.
- Developed and maintained comprehensive process documentation, ensuring consistency and quality in task execution.
- Led regular team meetings to review performance metrics, set goals, and discuss strategies for achieving targets.
- Cultivated culture of continuous improvement, encouraging team members to contribute ideas for enhancing processes.
- Enhanced team productivity by introducing innovative process improvement strategies.
- Evaluated existing processes on ongoing basis, implementing incremental improvements to drive long-term success.
- Coordinated with IT department to troubleshoot and resolve system issues, minimizing downtime and maintaining productivity.
- Evaluated customer needs and feedback to drive product and service improvements.
- Maintained database systems to track and analyze operational data.
- Conducted regular reviews of operations and identified areas for improvement.
- Gathered, organized and input information into digital database.
- Collected, arranged, and input information into database system.
- Optimized customer experience by delivering superior services and effectively troubleshooting issues.
- Generated reports detailing findings and recommendations.
- Developed effective improvement plans in alignment with goals and specifications.
- Evaluated staff performance and provided coaching to address inefficiencies.
- Educated staff on organizational mission and goals to help employees achieve success.
- Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
- Created and managed project plans, timelines and budgets.
- Helped meet changing demands by recommending improvements to business systems or procedures.
- Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
- Devised and implemented processes and procedures to streamline operations.
- Frequently inspected production area to verify proper equipment operation.
- Observed packing operations to verify conformance to specifications.
- Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
- Supported creation of detailed, technical financial models to value potential acquisition targets.
Executive-Regulatory Affairs
Plethico Pharma Limited
08.2015 - 02.2016
- Established long-term client relationships through consistent delivery of high-quality products and services.
- Enhanced customer satisfaction by streamlining communication channels and improving response times.
- Developed innovative solutions to complex problems, resulting in improved organizational performance.
- Mentored junior staff members for accelerated career growth, developing future leaders within the organization.
- Support of Renewal for Global Market.
- Coordination with global sites and clients for regulatory submission and strategy.
- Well acquainted with the eCTD and ISI tool to Publishing and submission procedure. i.e Create bookmarks and hyperlinks with ease, Manage, validate and audit- all of links and bookmarks at once and validate their accuracy, splitting or merging PDF files to stamping and watermarking, Enhance the quality of PDF files. Easy generation to hyperlinking or bookmarking. Ensures the accuracy of links re-paginate pages or modify documents.
- Preparation and filing of submissions to regulated and semi regulated authorities in CTD format. Finalization, review and regulatory compliance of submissions related documents. Review of Quality Documents (BMR & BPR, Raw Material, API/FP specification and analytical procedures, In-process specifications and analytical procedures, stability protocol, stability study report and packaging material specifications and analytical procedures).
- Gap analysis of dossiers for new submissions.
- Coordinating with the Clients & other teams which are involved in scheduling & planning
- Achieved company growth by implementing strategic marketing plans and business development initiatives.
- Managed cross-functional teams for successful project completion within budgetary constraints and deadlines.
- Implemented cost-saving measures through reevaluation of supply chain management practices.
- Collaborated with stakeholders to develop actionable strategies that aligned with corporate goals and objectives.
- Located bottlenecks to streamline existing processes.
- Assessed and analyzed departmental budgets to find ways to minimize expenses and optimize profits.
- Expanded market presence by identifying new business opportunities and forging strategic partnerships.
- Reviewed employee concerns and new opportunities to drive business strategies.
- Elevated customer service standards by introducing new training programs for front-line staff.
- Enhanced online presence and e-commerce sales through overhaul of company website and digital marketing strategies.
- Negotiated high-value contracts with key suppliers, reducing material costs and improving profit margins.
- Boosted team morale and productivity through implementation of comprehensive employee development program.
- Implemented cutting-edge technology solutions to improve data analytics, enabling more informed decision-making.
- Orchestrated successful turnaround strategy for underperforming business units, restoring profitability within year.
- Implemented company-wide sustainability program, reducing environmental impact and achieving industry recognition.
- Secured substantial media coverage for company initiatives, amplifying brand visibility and public engagement.
- Drove significant growth in annual revenue by identifying and penetrating new market segments.
- Led cross-functional team to develop new product line, which was launched ahead of schedule and under budget.
- Reduced employee turnover by establishing robust hiring process and fostering positive work culture.
- Optimized supply chain operations, ensuring timely delivery of products while minimizing logistics costs.
- Cultivated high-performance organizational culture, aligning employee goals with corporate objectives and rewarding excellence.
- Spearheaded company rebranding initiative, resulting in significantly improved market presence and customer engagement.
- Negotiated favorable terms in mergers and acquisitions, significantly expanding company's market share and capabilities.
- Conducted comprehensive market research to guide development of highly successful new service offering.
- Improved stakeholder satisfaction with regular communication and updates on project progress and outcomes.
- Enhanced operational efficiency by streamlining workflow processes across multiple departments.
- Developed strategic partnerships with industry leaders, enhancing company reputation and access to new customers.
- Achieved industry-leading customer satisfaction scores by revamping customer feedback and resolution process.
- Reported issues to higher management with great detail.
- Interacted well with customers to build connections and nurture relationships.
- Handled problematic customers and clients to assist lower-level employees and maintain excellent customer service.
- Trained and guided team members to maintain high productivity and performance metrics.
- Negotiated price and service with customers and vendors to decrease expenses and increase profit.
- Assisted in recruiting, hiring and training of team members.
- Cultivated and strengthened lasting client relationships using strong issue resolution and dynamic communication skills.
- Managed purchasing, sales, marketing and customer account operations efficiently.
- Tracked employee attendance and punctuality, addressing repeat problems quickly to prevent long-term habits.
- Observed each employee's individual strengths and initiated mentoring program to improve areas of weakness.
- Updated and resolved incidents and managed accessorial charges objectively while maximizing profit.
- Scheduled employees for shifts, taking into account customer traffic and employee strengths.
- Reduced operational risks while organizing data to forecast performance trends.
- Monitored daily cash discrepancies, inventory shrinkage and drive-off.
- Reduced budgetary expenditures by effectively negotiating contracts for more advantageous terms.
- Tracked trends and suggested enhancements to both challenge and refine company's product offerings.
- Implemented innovative programs to increase employee loyalty and reduce turnover.
- Supervised creation of exciting merchandise displays to catch attention of store customers.
- Launched staff engagement, gender diversity and cultural programs in addition to robust reporting tool that increased operational quality.
- Reduced financial inconsistencies while assessing and verifying billing invoices and expense reports.
- Implemented business strategies, increasing revenue, and effectively targeting new markets.
- Recruited, hired, and trained initial personnel, working to establish key internal functions and outline scope of positions for new organization.
- Raised property accuracy and accountability by creating new automated tracking method.
- Identified and qualified customer needs and negotiated and closed profitable projects with high success rate.
Executive-Regulatory Affairs
Piramal Pharma Limited
07.2014 - Current
- Compilation and submission of Dossier (ANDS) (Module 1 to 5) in CTD and eCTD format as per Health Canada Guidelines.
- Coordination with clients for project updates and requirements.
- Supervised response for the ANDS submission.
- Post-NOC Changes as per market and business requirements.
- Product Monograph updates with HC-SC-3011 .
- Due-Diligence of dossiers (in-license and out-licensed products).
- DMF Review.
- Preparation and filing of submissions to regulated and semi regulated authorities in CTD format.
- Finalization, review and regulatory compliance of submissions related documents.
- Review of Quality Documents (BMR & BPR, Raw Material, API/FP specification and analytical procedures, In-process specifications and analytical procedures, stability protocol, stability study report and packaging material specifications and analytical procedures).
- Gap analysis of dossiers for new submissions.
- Coordinating with the Clients & other teams which are involved in scheduling & planning
- Compilation of dossier for Semi-Regulated market in CTD and country specific formats.
- Review of Quality documents (BMP, BPR, AMVs, and other CMC supporting documents).
- Review of labelling material.
- Coordination with site for requirement of documents.
- Identified and qualified customer needs and negotiated and closed profitable projects with high success rate.
- Raised property accuracy and accountability by creating new automated tracking method.
- Recruited, hired, and trained initial personnel, working to establish key internal functions and outline scope of positions for new organization.
- Implemented business strategies, increasing revenue, and effectively targeting new markets.
- Reduced financial inconsistencies while assessing and verifying billing invoices and expense reports.
- Launched staff engagement, gender diversity and cultural programs in addition to robust reporting tool that increased operational quality.
- Supervised creation of exciting merchandise displays to catch attention of store customers.
- Implemented innovative programs to increase employee loyalty and reduce turnover.
- Tracked trends and suggested enhancements to both challenge and refine company's product offerings.
- Reduced budgetary expenditures by effectively negotiating contracts for more advantageous terms.
- Monitored daily cash discrepancies, inventory shrinkage and drive-off.
- Reduced operational risks while organizing data to forecast performance trends.
- Scheduled employees for shifts, taking into account customer traffic and employee strengths.
- Updated and resolved incidents and managed accessorial charges objectively while maximizing profit.
- Observed each employee's individual strengths and initiated mentoring program to improve areas of weakness.
- Tracked employee attendance and punctuality, addressing repeat problems quickly to prevent long-term habits.
- Managed purchasing, sales, marketing and customer account operations efficiently.
- Cultivated and strengthened lasting client relationships using strong issue resolution and dynamic communication skills.
- Assisted in recruiting, hiring and training of team members.
- Negotiated price and service with customers and vendors to decrease expenses and increase profit.
- Trained and guided team members to maintain high productivity and performance metrics.
- Handled problematic customers and clients to assist lower-level employees and maintain excellent customer service.
- Interacted well with customers to build connections and nurture relationships.
- Reported issues to higher management with great detail.
- Achieved industry-leading customer satisfaction scores by revamping customer feedback and resolution process.
- Developed strategic partnerships with industry leaders, enhancing company reputation and access to new customers.
- Enhanced operational efficiency by streamlining workflow processes across multiple departments.
- Improved stakeholder satisfaction with regular communication and updates on project progress and outcomes.
- Conducted comprehensive market research to guide development of highly successful new service offering.
- Negotiated favorable terms in mergers and acquisitions, significantly expanding company's market share and capabilities.
- Spearheaded company rebranding initiative, resulting in significantly improved market presence and customer engagement.
- Cultivated high-performance organizational culture, aligning employee goals with corporate objectives and rewarding excellence.
- Optimized supply chain operations, ensuring timely delivery of products while minimizing logistics costs.
- Reduced employee turnover by establishing robust hiring process and fostering positive work culture.
- Led cross-functional team to develop new product line, which was launched ahead of schedule and under budget.
- Drove significant growth in annual revenue by identifying and penetrating new market segments.
- Secured substantial media coverage for company initiatives, amplifying brand visibility and public engagement.
- Implemented company-wide sustainability program, reducing environmental impact and achieving industry recognition.
- Orchestrated successful turnaround strategy for underperforming business units, restoring profitability within year.
- Implemented cutting-edge technology solutions to improve data analytics, enabling more informed decision-making.
- Boosted team morale and productivity through implementation of comprehensive employee development program.
- Negotiated high-value contracts with key suppliers, reducing material costs and improving profit margins.
- Established long-term client relationships through consistent delivery of high-quality products and services.
- Enhanced customer satisfaction by streamlining communication channels and improving response times.
- Developed innovative solutions to complex problems, resulting in improved organizational performance.
- Mentored junior staff members for accelerated career growth, developing future leaders within the organization.
- Prepared annual data to determine metrics for operational performance.
- Optimized operational efficiency by redesigning processes, systems, and workspaces for increased productivity.
- Interviewed, recruited and trained new onboarding candidates.
- Achieved company growth by implementing strategic marketing plans and business development initiatives.
- Assisted in employee appraisals, promotions and terminations based on performance reviews.
- Identified trends and assessed opportunities to improve processes and execution.
- Collaborated with stakeholders to develop actionable strategies that aligned with corporate goals and objectives.
- Implemented cost-saving measures through reevaluation of supply chain management practices.
- Managed cross-functional teams for successful project completion within budgetary constraints and deadlines.
- Located bottlenecks to streamline existing processes.
- Assessed and analyzed departmental budgets to find ways to minimize expenses and optimize profits.
- Expanded market presence by identifying new business opportunities and forging strategic partnerships.
- Reviewed employee concerns and new opportunities to drive business strategies.
- Elevated customer service standards by introducing new training programs for front-line staff.
- Enhanced online presence and e-commerce sales through overhaul of company website and digital marketing strategies.
Education
Master of Science - Pharmaceutices
DBCOP
Nagpur, India 06.2012 - Current
Associate of Science - PGDCCA
RITM University
Nagpur 07.2009 - Current
Bachelor of Science - B.Pharmacy
SVCP
Indore 07.2006 - Current
Associate of Science - Diploma in Pharmacy
KTM
Jabalpur, India 07.2003 - Current
Associate of Science - 12th
SSM, Chhindwara
Bhopal, India 07.2002 - Current
Skills
Process analysis
Report analysis
Quality assurance
Presentations
Knowledge of CTD, ACTD, and eCTD formats
Well conversant with e-CTD/SPL Publisher/Submissions Acquainted with eCTD software like Pharma Ready (Take Solution)
Knowledge of Clinical and nonclinical documents
Develops / validates the project estimate
Establishes budgets based on the approved project estimate Manages cost commitments
Reviews and approves vendor invoices
Assesses and submits project accruals to accounting personnel Implements and manages the change control process
Build and reviewed SOP to ensure strong food prints in Clinical Study Solutions
Accomplishments
Achieved 95% customer satisfaction score (CSAT) on average as Project Manager for Rare disease, Pulmonary, Ophthalmology and general indication studies.
Conducted Project Management training sessions to upskill and onboard new Project Management Analyst.
Implementing decentralized solutions across organization and supporting key clients.
Build and support review of SOP to ensure strong food prints of organization in Clinical Industry.
Awarded for developing and implementing business improvement methods which saved time and cost of organization.
Software
Timeline
Process Associate
Tata Consultancy Services
02.2016 - Current
Executive-Regulatory Affairs
Plethico Pharma Limited
08.2015 - 02.2016
Executive-Regulatory Affairs
Piramal Pharma Limited
07.2014 - Current
Master of Science - Pharmaceutices
DBCOP
06.2012 - Current
Associate of Science - PGDCCA
RITM University
07.2009 - Current
Bachelor of Science - B.Pharmacy
SVCP
07.2006 - Current
Associate of Science - Diploma in Pharmacy
KTM
07.2003 - Current
Associate of Science - 12th
SSM, Chhindwara
07.2002 - Current
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