Deepali Akhade

Results-oriented Pharmacovigilance (PV) & Drug Safety Specialist and Qualified Health Professional (B.Pharm) with over 5 years of experience executing end-to-end case management, regulatory compliance (FDA, EMA, MHRA), and aggregate reporting. Proven track record of monitoring and documenting safety data to identify trends while managing the PV inbox, individual/aggregate reports, and local risk management activities. Possesses an MSc in International Business (UK), combining deep drug safety operations with an "Aim Higher" mindset to move with urgency, foster cross-functional business collaboration, and deliver inspection-ready data that impacts patients positively.

Drug Safety Data Analyst - Cognizant Technology Solutions

(2023-01 - 2023-08)

• Manage and process pharmacovigilance data accurately and on time, supervising the high-volume PV inbox, individual/aggregate reports, and SUSAR management to maintain a 100% compliance rate with global regulatory timelines.
• Monitor and document safety data regularly using Oracle Argus and ArisG to identify trends, clusters, and potential safety issues, transforming complex data into actionable insights for corporate and health authority queries.
• Maintain and update PV procedures and SOPs in total alignment with updated FDA and EU GVP standards, reducing potential compliance risks by 15%.
• Support the MSO/PVM and Senior PV Officer by steering cross-functional collaboration to ensure constant inspection and audit readiness, proactively resolving data discrepancies before submission.
• Uphold ethical and safety standards by enforcing robust data integrity protocols, taking personal accountability for governance knowledge within a high-pressure, regulated environment.

Business Process Associate - Tata Consultancy Services (TCS)

(2019-03 - 2022-10)

• Direct safety data reconciliation, local literature monitoring, and complex pharmacovigilance documentation workflows for tier-1 global pharmaceutical clients.
• Investigate and resolve CAPAs (Corrective and Preventive Actions) to support training and compliance activities, contributing directly to a 100% success rate in external regulatory audits.
• Optimize reporting workflows and local risk management activities using Agile principles, eliminating process bottlenecks and improving team efficiency by 20%.
• Foster timely and accurate communication with Business Unit functions, bridging operational gaps under the guidance of senior safety leadership.
• Mentor and train a team of 5+ junior associates on safety data standards, company policies, and MedDRA coding to maximize baseline output quality.
• Manage PV administrative tasks, maintaining comprehensive hard copy and electronic files to ensure all client data repositories remain audit-ready.

Quality Assurance (QA) Trainee - Anant Pharmaceuticals

(2018-02 - 2018-08)

• Executed internal GMP auditing and updated local validation procedures to maintain 100% compliance with local health authority safety standards.
• Organized and archived regulatory quality records, facilitating smooth data retrieval for internal stakeholders and external compliance reviews.

MSc - International Business - University of Lincoln, UK (2024 - 2025)

PG Diploma - Advanced Pharmacy & Regulatory Affairs - Inclination Institute, India (2018 - 2018)

Bachelor of Pharmacy - Pharmacy - Savitribai Phule Pune University, India (2016 - 2016)