Himanshu Kharkwal

WORK HISTORY

EDUCATION

SKILLS

ABOUT HIMANSHU KHARKWAL

I am an ICH-GCP-certified Clinical Research Professional with over 12 years of diverse experience spanning clinics, academia, biotech, and large pharmaceutical organizations. My career combines scientific expertise, leadership, and a strong focus on advancing patient safety and clinical research.In my current role in Pharmacovigilance, I lead global safety activities for products in development. This includes signal detection, risk management, and the preparation of critical regulatory documents such as DSURs, PBRERs, PADERs, Investigator Brochures (IBs), and Clinical Study Reports (CSRs). I collaborate closely with safety physicians, cross-functional teams, and global stakeholders to ensure regulatory compliance and deliver exceptional quality.My experience includes managing complex interventional and observational clinical trials, particularly in oncology, vaccines, and virology. I work extensively with CROs and sponsors, driving operational excellence and ensuring seamless execution of studies across diverse geographies. I am recognized for my meticulous attention to detail, problem-solving skills, and ability to publish high-quality data that consistently meet and exceed objectives.Key Strengths:Pharmacovigilance & Risk Management: Expertise in signal detection, safety surveillance, and global regulatory compliance.Regulatory Document Preparation: Skilled in authoring DSURs, PBRERs, PADERs, IBs, CSRs, and other safety-related documents.Therapeutic Expertise: Specialization in oncology, vaccines, immunotherapies, and molecular diagnostics.Collaboration: Proven ability to lead cross-functional teams and manage relationships with CROs, sponsors, and global stakeholders.Operational Leadership: Strong organizational skills to oversee multiple projects simultaneously in dynamic, multicultural environments.Audit & Quality Management: Experienced in conducting audits, writing audit responses, and ensuring GCP compliance.I am passionate about improving patient safety through innovative solutions, strong collaborations, and a commitment to excellence in clinical research. With a results-driven approach and global perspective, I aim to contribute to better health outcomes and advance the future of medicine.