HAROM Solutions prides itself on employing the experts from Pharmacovigilance industry. Our team of experts strives to provide each client Pharmacovigilance solutions using inventive, web-enabled technology to tackle key challenges in Pharmacovigilance data management posed by the new legislation using skills and knowledge gained from over 20 years of Pharmacovigilance experience.
HAROM’s PHARMACOVIGILANCE TEAM
THE CREATORS
SUNIL VERMA, Founder Director
Founder and Managing Director, Sunil is a Qualified Pharmacovigilance professional with over 10 years of experience in Pharmaceutical industry and is currently working as QPPV, PHARMACOVIGILANCE CONSULTANT and as TECHNICAL EXPERT nationally and internationally located clients. With his strategic and creative thinking, he continues to deliver quality focused and performance driven services to all HAROM’s clients.
Dr. Sandeep Rana, Managing Director and Head of Global operations
Dr. Rana is responsible for the ongoing development and management of HAROM Solution’s Pharmacovigilance operations. He has total of 12 years of experience in the clinical research and Pharmacovigilance industry with >6 years in holding Training and Operations as Vice President.
THE TEAM
THE LEADERS
With their vast experience in Pharmacovigilance Operations, they perform as a functional leads of Case Management processes from adverse event intake to submission. They oversees the collection, triage, processing, safety review, and reporting of adverse event data in compliance with applicable FDA and global regulations and HAROM Solution’s standard operating procedures and guidelines.
THE TEAM
THE TECHNICAL SPECIALISTS
Pharmacovigilance Research Scientist, Dedicated team from Medical, Dental, Pharma and Life Sciences education. As a member of the Drug Safety and Pharmacovigilance department in HAROM Solutions, the team of our Pharmacovigilance Research Scientist is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations and HAROM’s standard operating procedures and guidelines.
THE QUALITY ASSURANCE SPECIALISTS
We have a dedicated team of Quality Specialists responsible for managing and maintaining the quality management system. This includes ensuring that critical documents (e.g. SOPs, inspection reports) are current and compliant. They assist in preparing clients for audits and inspections and to co-ordinate action plans resulting from audits/inspections. They are also responsible for looking after training plans and ensuring that all personnel are suitably trained for their role.
THE TRAINERS
We have highly experienced, skilled and motivated trainers comprising Doctors & Pharmacovigilance Professionals. Our Subject matter experts provide training on the therapeutic area of the product under development and specific training on the science related to the investigational product. Training related specifically to Pharmacovigilance is continuous, with more senior staff reviewing and mentoring the junior staff. Beyond a certain size, however, staff specifically dedicated to performing Pharmacovigilance training.
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