Jhumi Jain
MS Regulatory Affairs ’25
Quality Assurance (R &D Pharmacovigilance) Co-op at Alnylam Pharmaceuticals

What challenge did you tackle during your co-op?

I was tasked with working with a team to ensure regulatory compliance and advancing global pharmacovigilance initiatives at Alnylam Pharmaceuticals, a company developing breakthrough RNAi therapeutics. The organization needed to maintain rigorous safety standards while navigating the full lifecycle of pharmaceutical products. This involved managing quality oversight for both commercialized and late-stage RNAi therapies, ensuring compliance with FDA, EMA, and international regulatory requirements, while supporting the safe delivery of life-changing medicines to patients with rare and devastating diseases. 

How did you approach solving this complex organizational challenge?

 I approached this systematically by embedding myself in both global pharmacovigilance quality oversight and clinical safety operations. I prioritized proactive quality management and continuous improvement. I worked collaboratively across cross-functional teams to bridge clinical development and post-market safety surveillance, ensuring that as Alnylam developed innovative RNA therapeutics, patient safety remained paramount at every stage. I made sure compliance wasn’t seen as a bureaucratic burden but as an essential component of responsible pharmaceutical development and patient protection. 

What skills did you develop and apply during this experience?

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