Rajesh Kumar Patidar

About Rajesh Kumar Patidar

I am a healthcare & drug safety professional with over a decade of experience spanning Pharmacovigilance, Aggregate Reporting, Risk Management, Medical Safety Writing, Automation Strategy, and Cross‑Functional Leadership across leading global organizations including Novartis, Merck, IQVIA, Covance, GSK, and Abbott.Currently, I work in Strategy for Aggregate Reports & Risk Management (AR & RM) at Novartis, where I drive short‑ and mid‑term strategic priorities (1–5 years) focusing on automation, operational excellence, regulatory compliance, and global portfolio delivery. I oversee end‑to‑end AR & RM operations—scheduling, preparation, QC, and dispatch—ensuring high‑quality, inspection‑ready submissions to Country Organizations worldwide.My core strength lies in transforming complex safety and regulatory processes through innovation, including:Implementing AI and advanced automation tools to simplify and accelerate AR & RM workflowsDriving process optimization, capacity planning, and scheduling excellenceLeading cross‑functional expert teams (Regulatory, Clinical, Marketing, Safety Science) to deliver global periodic and risk‑management reportsTranslating evolving regulatory guidelines into practical SOPs, templates, and systemsStrengthening governance, CAPA management, and quality frameworks across PS & PVWith hands‑on expertise in authoring and reviewing major global safety reports—RMPs, PBRERs/PSURs, DSURs, ACOs, SERs, PADERs, and HA‑requested documents—I bring deep technical and strategic understanding across the full PV value chain, from ICSR case processing → aggregate reporting → benefit–risk evaluation → automation strategy.Earlier in my career, I worked in sales and medical affairs, which gives me a strong foundation in stakeholder engagement, communication, and commercial understanding—skills I now apply in cross‑functional leadership and change management.I am passionate about building high-performing teams, mentoring new associates, enabling global capability uplift, and shaping the future of safety reporting through AI, digital transformation, and lean process design.Areas of Expertise:I’m motivated by work that improves patient safety, builds scalable systems, and prepares organizations for the next generation of regulatory and technological transformation.

Experience

1. Manager (Strategy - Aggregate Reports & Risk Management Plan)

   Novartis

   Jan 2026 — Present · Hyderabad, IN

   Support implementing the strategy for AR & RM in the short and medium term (1 to 5 years) to ensure there is an ongoing cycle of assessment, innovation, and improvement with the aim of achieving high quality deliverables in a cost-effective manner with special attention to implementing automation solutions. Manage the operations of AR & RM for Novartis Development product portfolio encompassing scheduling, preparation, quality review, and dispatch to Country Organization (CO) to ensure compliance with worldwide regulations with maximum efficiency. Driving continuous operational excellence and ensuring efficient resource utilization. As assigned lead/ participate in projects of strategic value for the future of PS & PV.1. Lead assigned PS & PV initiatives to develop business solutions and meet emerging regulatory requirements, by directing cross-functional teams, managing progress, quality and timely completion of deliverables, and reporting progress to PS & PV leadership.2. Drive innovation and process improvements for the AR & RM by optimizing the global aggregate report schedule and enhancing the quality and compliance of all global periodic and risk management reports in line with Company standards, supporting investigations and corrective actions through simplified processes.3. As a business lead/ Co lead support in developing, testing and implementation of Artificial Intelligence solutions and other advanced tools to simplify and facilitate core activities of the AR & RM team (including support of the preparation of relevant manuals).4. Support Global PS & PV initiatives to develop business solutions and meet emerging regulatory requirements, by directing cross-functional teams, managing progress, quality and timely completion of deliverables, and reporting progress to PS & PV leadership.

Education

• Rajasthan University of Health Sciences, Jaipur

  Bachelor’s Degree, Bachlor in Pharmacy

  2008 — 2012

• Nirma University

  Master in Pharmacology, Pharmacology

  2012 — 2014

Skills

• Healthcare
• Pharmaceutical Research
• Microsoft Excel
• Powerpoint
• Standard Operating Procedure (Sop)
• Teamwork
• Pharmacology
• Leadership
• Microsoft Office
• English
• Regulatory Affairs
• Lifesciences
• Medical Writing
• Pharmacovigilance
• Pharmaceutical Industry
• Dispensing of Medicines (Retail Pharmacist)
• Research
• Microsoft Word