Biranchi Kumar

About Biranchi Kumar

As a seasoned leader in Pharmacovigilance and Patient Safety Operations, I bring over two decades of experience driving global safety strategy, compliance, and operational excellence across clinical and post-marketing domains. In my current role as Sr. Director, Patient Safety Operations, I lead large, cross-functional teams to deliver high-impact safety outcomes that protect patients and enable regulatory success.My expertise spans Safety Operations, Quality & Compliance, global transitions, and team building at scale — all while staying ahead of the fast-evolving life sciences landscape. I’ve led enterprise-wide transformations in case processing, implemented automation and analytics tools, and built governance frameworks aligned with global health authority expectations.Looking ahead, I’m focused on shaping the future of PV through digital innovation, data-driven decision-making, and leadership development. I’m passionate about mentoring the next generation of PV professionals, fostering a culture of accountability and agility, and aligning safety operations with broader organizational and patient-centric goals.Whether navigating complex regulatory landscapes or driving operational strategy, I strive to elevate pharmacovigilance as a strategic enabler in drug development, commercialization, and lifecycle management.

Experience

1. Sr Director Patient Safety Solutions

   Fortrea

   May 2025 — Present

   Lead global patient safety operations, driving strategic transformation, compliance, and innovation across clinical and post-marketing programs- Oversee cross-functional teams to deliver high-impact safety outcomes aligned with regulatory expectations and organizational goals- Spearhead enterprise-wide initiatives in automation, analytics, and governance to enhance operational efficiency and inspection readiness- Direct proposal development, budget planning, and bid defense activities for large-scale pharmacovigilance programs, ensuring competitive positioning and client alignment- Partner with business development and operational leads to shape solution design and delivery models tailored to client needs and evolving industry dynamics- Champion talent development, mentoring future PV leaders and fostering a culture of agility, accountability, and continuous improvement.

Education

• Al-Ameen college of Pharmacy

  Academic; M.Pharm

  2006 — 2008

• Government College of Pharmacy

  Bachelor of Pharmacy (B.Pharm.)

  2001 — 2005

Skills

• Meddra
• Regulatory Affairs
• Medical Writing
• Ich-Gcp
• Gcp
• Clinical Trials
• Pharmaceutical Industry
• Sop
• Drug Safety
• CRO
• Process Improvement
• Oncology
• Quality and Compliance
• Pharmacovigilance