Mayuresh Kale

Results-driven Pharmacovigilance professional with experience in drug safety operations, adverse event case processing, regulatory safety reporting, and team coordination across clinical trial and post-marketing environments. Skilled in safety data review, workflow oversight, SOP compliance, cross-functional collaboration, and ensuring timely, accurate submissions to regulatory authorities. Strong knowledge of global pharmacovigilance regulations and guidelines, with proven ability to support team performance, maintain reporting quality, and drive process improvements in fast-paced safety environments.

Assistant Manager at Superdrug plc (2023-08 – 2026-04)

• Led a team of 21 Sales Assistants including 2 Team Leads, ensuring streamlined operations and delivering excellent customer service.
• Analyzed and solved technical inquiries from customers and suppliers, relating to day-to-day operational functionality.
• Built and developed relationships with key customers, anticipating, diagnosing, and interpreting their needs.
• Formulated creative solutions leveraging technology that exceeded customer requirements and expectations.
• Drove insights from large data sets and built customized reports that supported customers' decision-making.
• Became a subject matter expert on various software products, including Sourcing Optimization, Automation, and Fulfillment Optimizer.
• Assisted with pre-sales meetings and demonstrations as a product technical expert, liaising with customers and scheduling training sessions to optimize product utilization.
• Collaborated closely with other teams and departments, including tier 2 support, customer success managers, to ensure high levels of customer satisfaction.
• Demonstrated strong organizational and time management skills in efficiently handling tasks assigned by management.
• Identified process improvement opportunities to enhance operational effectiveness and improve team productivity, resulting in increased sales and reduced unnecessary work hours.
• Developed and managed a training plan for the team, provided coaching and mentorship, conducted performance evaluations, and established an inclusive work culture.

Programmer at IQVIA Asia Pacific (2021-05 – 2023-01)

• Managed clinical trial databases like Argus, ensuring data quality and regulatory compliance across multiple projects.
• Acted as the primary point of contact for multiple projects, ensuring effective communication and timely delivery of project updates to stakeholders.
• Provided remote technical support to clinical teams, optimizing systems for patient safety data collection and reporting.
• Collaborated with cross-functional teams to implement new features for clinical trial systems, improving data accuracy.
• Optimized the ticket assignment algorithm by integrating machine learning; decreased average handling time by 25% and boosted customer satisfaction scores by 15% through faster resolutions.
• Demonstrated expertise in configuring applications autonomously and effectively collaborating with the wider support team.
• Contributed to improving user access maintenance and basic project building for DistilleR and Apex.
• Responsible for the upkeep and management of various company databases like Argus, Apex, and DistilleR.
• Devised and executed comprehensive access control protocols for OCT tracker in a multi-project environment; boosted system security by 50% and decreased access-related support requests by 25%.
• Aided in fostering a supportive team environment by delivering top-notch customer service and contributing to the onboarding process of new team members.
• Coded, tested and debugged programs in accordance with established standards.
• Created and modified existing database structures to improve system performance.
• Monitored systems performance to diagnose issues related to application design or coding errors.
• Collaborated with other developers on cross-functional teams to implement features within tight deadlines.
• Deployed applications into production environment ensuring successful integration with external systems.
• Provided technical support by troubleshooting customer problems related to software applications.

Senior Drug Safety Associate (PV Officer) at BIOCLINICA (2020-01 – 2021-04)

• Managed multiple projects simultaneously while meeting tight deadlines and maintaining high-quality work standards in a fast-paced environment.
• Handling Workflow management (WFM) for operational team.
• Managing allocation of cases amongst 200 associates (including Case Processing, Medical Reviewer and Quality Review users).
• Prioritizing LTD and Regulatory due cases. Oversaw the suppression workflow and monitored translation workflow via Multi-Trans.
• Actively involved in Leave planning and weekend working management. Publishing team productivity and quality metrics on daily basis.
• Backup user for EudraVigilance workflow.
• Handling Pre-intake activity for mailbox cases and Post-intake for rest cases.
• Supported in pregnancy case processing team.
• Developed innovative solutions for complex case processing challenges, enhancing overall efficiency within the department.
• Initiated process improvement initiatives that resulted in reduced case processing times without compromising data quality or integrity.
• Responsible for maintaining clarification log for constant updates and conveying the same to the team.
• Supported in PQ testing for Safety Case Tracker (SCT).

Junior Safety Data Analyst at Covance Scientific Solutions (2018-03 – 2020-01)

• Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
• Ensure compliance of operations with governing regulatory requirements.
• Create, maintain and assume accountability for a culture of high customer service.
• Execute drug safety data management processes – a combination of case intake, triage, case entry, medical coding, narrative writing, case follow-up.
• Assume responsibility for quality of data processed.

Inter-Data Analyst (Data Acquisition) at Innoplexus AG (2017-12 – 2018-03)

• Extracted, transformed, and loaded (ETL) data from multiple sources, ensuring accurate data flow into the data warehouse.
• Performed data acquisition from various APIs, external databases, and cloud services, integrating real-time data for business intelligence purposes.
• Designed and implemented SQL queries to retrieve and validate data from relational databases, improving accuracy of reporting and decision-making.
• Collaborated with business stakeholders to gather data requirements and ensure the data acquisition processes aligned with business objectives.

Master of Business Administration – Dublin Business School (2024-02)

Bachelors of Pharmacy in Pharmacy – Amravati University (2017-07)