Strategic Pharmacovigilance Leader | AI & Automation Enthusiast | Compliance expert

Navigating the Complexities of Pharmacovigilance

At SRdrugsafety, I share my professional journey in drug safety and compliance. Join me as I delve into insights and advancements that shape the pharmaceutical landscape. With over 14 years of experience in global pharmacovigilance, regulatory compliance, and process automation, I specialize in transforming drug safety operations through innovative and scalable solutions

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Years in Pharmacovigilance & Drug Safety

Regulatory Compliance Achieved

Process Efficiency Improvement Through Automation

My Expertise

Comprehensive Services in Drug Safety and Compliance

Pharmacovigilance Services

I provide expert pharmacovigilance services to ensure drug safety. My focus is on monitoring, assessing, and mitigating risks associated with pharmaceutical products, ensuring compliance with regulatory requirements.

Regulatory Compliance

With extensive knowledge in regulatory frameworks, I ensure that all safety processes align with industry standards. I guide organizations in navigating compliance challenges and adapting to evolving regulations.

Automation Solutions

I specialize in implementing automation solutions that streamline safety reporting processes. By leveraging technology, I enhance efficiency while maintaining accuracy and compliance in pharmacovigilance.

Project Management

I offer project management services tailored to the pharmaceutical industry. My expertise ensures that safety projects are executed on time, within budget, and in adherence to regulatory timelines.

Who I Am

Discover the Journey and My Expertise

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Professional Summary

I am a seasoned pharmacovigilance expert and project manager with a strong track record in compliance, efficiency and team leadership. I possess deep expertise in regulatory affairs, AI-driven automation, and global case processing, successfully managing transitions, audits, and process optimizations across various pharmaceutical portfolios.

Key Strengths

Leadership & team development

Regulatory compliance (FDA, EMA, MHRA & local HAs)

AI & Automation in Pharmacovigilance

Business partner reconciliation & stakeholder engagement

Data Analysis & Process Optimization

Certifications

PMP® (Project Management Professional)

Lean Practitioner

Leveraging Generative AI for Project Management

Education:

MSc. Drug Discovery – University of Bradford, UK

B. Pharmacy – Madras Medical College, India

My Professional Journey

Insights from My Work Experience in Drug Safety

Syneos Health, Bangalore

2023- 2024, Manager Pharmacovigilance & safety

Spearheaded automation initiatives that increased efficiency by 40%.

Successfully led four global health authority audits, ensuring compliance and operational excellence.

Implemented Power Automate and SharePoint solutions to optimize affiliate activities and streamline reporting.

Awarded the Frontline Leadership Award for stabilizing the Europe affiliate and driving operational transformation.

IQVIA RDS India Pvt Ltd

2019 – 2023, Associate Manager, Safety Operations

Delivered 15% efficiency and 20% quality improvements through lean methodologies and predictive analytics.

Led the migration to a new safety database, ensuring a seamless transition and full compliance.

Managed a team of 18, exceeding KPIs for 20 consecutive months.

Bioclinica India Pvt Ltd

2013 – 2019, Assistant Project Manager & Various other roles

Optimized workload distribution, improving resource utilization and SLA compliance.

Designed training programs that increased deliverable quality and knowledge retention.

Successfully completed multiple regulatory audits with zero major findings.

Recent Work

Explore My Latest Projects in Drug Safety

AI-Driven PV Case Intake Platform (iRxsafe)

Built an AI-powered platform that automates adverse event case intake, triaging, and processing.
Integrated human-in-the-loop review to refine AI accuracy.
Achieved faster case processing and ensured regulatory compliance.

Process Automation in PV Operations

Implemented Power Automate workflows, reducing manual effort by 40%.
Streamlined affiliate management processes, improving transparency and productivity.

Regulatory Compliance & Audit Success

Led multiple successful audits across US, EU, and APAC regions.
Designed audit-ready workflows that improved compliance by 99%.

Quality Improvement & Efficiency Gain

Delivered 15% efficiency and 20% quality improvements through lean methodologies and predictive analytics.

What Others Say

Client Experiences and Feedback

Sowndararajan is a seasoned PV professional, with strong process knowledge and excellent people management skills. Rajan has proven record of working in challenging projects and has demonstrated resilience and strong leadership skills to achieve the project goals successfully. Rajan has deep interest in technology and he has been very innovative in providing solutions to PV systems and tools. As a people manager, I have seen how Rajan worked with his team and supported in their development by identifying their strengths and weakness. This led to him forming a strong team who were highly engaged and motivated and overall a team with high morale. Rajan’s ability to understand the client requests and providing timely response and solutions has resulted in a positive relationship with the clients he has worked with. Overall it was a pleasure working with Rajan and I wish him all success in his future endeavours. I highly recommend Rajan for suitable roles in the PV industry.

Mahalakshmi MuthuvelAssociate Director, Safety & PV Syneos Health

Sowndararajan is an exceptional talent. Calm composed and matured , he has the ability to handle any situation with the utmost diligence. He is an asset to any organisation and I wish him all the best!! I highly recommend for anyone needing guidance in drug safety. They provided exceptional support and insights.

Dipanjan Chaudhuri Vice-president, 4C pharma

I highly recommend Sowndararajan Ramalingam as an outstanding professional who would be a great asset to any organization. His extensive knowledge, dependable nature, proactive attitude, and team-playing skills make him an excellent candidate for any role in Pharmacovigilance or related fields.

Vinay Alaparthi Principal Quality engineer, Aris Global

Let’s Connect

📩 Let’s connect! Whether you’re looking for expert insights, collaboration opportunities, or hiring for a leadership role, feel free to reach out.
Email: ramalingamsowndar@gmail.com Phone: (+91) 95352 32422
LinkedIn: Sowndararajan Ramalingam

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