Our team is aware and prepared to meet the most stringent deadlines while delivering a comprehensive outsourced solutions
With a strong emphasis on quality and compliance, as well as a sharp eye for identifying the best technological and process-based solutions to expedite results, Dr. Anit is an enthusiastic & self-motivated individual. With a strong foundation in medicine and research from All India Institute of Medical Sciences New Delhi, one of the most prestigious medical institutes in the country he assembles the best team of professionals in the fields of drug safety, pharmacovigilance, medical information, and medical writing. He founded a firm providing services related to drug safety such as case processing, signal management, risk management, aggregate reporting, and clinical safety, that routinely meet and surpass client expectations.
He has overseen multiple technology development and build projects, emphasising methods to raise accuracy, speed, efficiency, and engagement with clients. He is passionate about discovering new and innovative solutions for unmet medical needs and serving the people with quality and ethical care. He brings in diverse perspectives and experiences to the team, as he has worked with renowned pharmaceutical giants. He stands for his work ethics, enjoys creating highly motivated teams, and is concerned with the productivity and welfare of his clients, co-workers, and the community. What motivates him in achieving better results is by utilising technology, real-world data, and other tools throughout the value chain. He values collaboration, innovation, and excellence, and strive to create a culture that fosters these values at PVG Pharmasciences
Dr. Nidhi is responsible for delineating company’s strategies and achieving PVG Pharmasciences goals. She works with the best team of PVG professionals supervising the execution of operational tasks with more than 10 years of expertise & deep understanding of clinical research drug safety, pharmaceutical industry, and pharmacovigilance. Dr. Nidhi’s business model is centered on being a Director of full-service Clinical Research Organization and direct the PVG Pharmasciences substantial organic expansion, and the development of a laser-focused strategy on PV Processes. She maintains good connections with internal & external stakeholders by maintaining a positive channel of communication. She has knowledge in PVG domain with her subject matter expertise in Clinical research and is passionate about overseeing clinical project management and regulatory compliance.
She has expertise in almost all major therapeutic areas especially Oncology, Cardiology, Respiratory, infectious diseases etc. She leads the team with a good knowledge in ICSR Processing, Literature monitoring, & reviewing various periodic safety update reports, risk management across PV processes. She also enjoys keeping herself abreast of various international PV regulatory guidelines, training and mentoring team members, sponsor interactions and strategizing and implementing improvements in processes. The enthusiasm that she carries, results in expediting the tasks of benefit-risk cycle and contribute to the development of life- changing medications & winning our client’s trust over years.
Dr. Ravichand is an independent, highly self- motivated individual who takes each day as learning and exploring new avenues and broaden his thinking canvas. He serves as a Medical Director in our team with 15 years of experience in the pharmaceutical industry in pharmacovigilance and clinical development across different phases of clinical trials. He is an experienced professional who is lead by an example to ensure effective and cooperative cross-functional team. Responsible for establishing & maintaining pharmacovigilance system, including all activities assessing and communicating safety information as well as risk management activities.
He has ability to oversee the safety profiles & emerging safety concerns and also acts as a central point of contact for Audits & inspections. Dr. Ravi ensures full and prompt response to any request from Regulatory authorities for the provision of information necessary for benefit -risk evaluation of the products in collaborations with relevant departments.
Dr. Shubhrata Pandey is a seasoned professional in Pharmacovigilance operations with an experience of more than 10 years. Dr. Shubhrata has extensive Knowledge in PVG operations and regulatory compliance at the local & international level for multiple regions. She has left an indelible mark during her tenure in companies like Indegene, Apcer Life Sciences and Pharmalex. Her expertise is across risk management plans across EU and US PV processes, addendum reports, summary bridging reports, safety database validation, literature monitoring, and ICSR processing. She has worked with national and international teams winning numerous accolades.
In addition, she takes pleasure in interacting with clients, staying current on international PV regulatory norms, giving trainings and guiding team members, and planning and executing PV process enhancements.
With more than 10 years of expertise in clinical research and pharmacovigilance, Praveen holds a great focus in pharma industry. He has overseen several client’s expectation regarding the quality and compliance for intricate analytical work. He has lead pharmacovigilance teams that carries out pharmacovigilance tasks for a range of international clients. Praveen’s expertise lies in signal management, aggregate reports, processing ICSR cases, processing and reporting SAE/SUSAR, safety management plans, SAE reconciliation plans, and more. Praveen has also contributed to signal and risk management discussions and have proficiency in ARGUS, MEdDRA coding, WHO DD coding combined with a strong foundation in adverse event reporting and regulatory compliance.
In order to ensure system and regulatory compliance, Praveen has been involved in the development of a pharmacovigilance unit and the steady scaling up of PV activities. In a variety of pharmacovigilance fields, he has led teams that have produced high-quality documentation & results.
Mandavi with her core Biomedical Sciences background joined PVG Pharmasciences team and is responsible for managing the company’s pharmacovigilance strategy, expanding the portfolio growth, and connecting & assisting clients to the right safety solutions via collaborations and partnerships. Mandavi’s ability to foster constructive communication is a means of preserving strong relationships with stakeholders. As an optimistic individual, she spearheads & implements best practices & innovative solutions that helps the organization in maximising their pharmacovigilance assets. Signal management, aggregate reports, handling ICSR instances, safety management plans, SAE reconciliation plans, and other areas of her interests. She possesses understanding of pharmacovigilance aspects and continuously strive for process improvement.
Her primary focus has consistently been on increasing customer engagements by combining regulatory knowledge, quality and compliance, and the introduction of cutting-edge services that support customer assets.
PVG Pharmasciences is looking for variety of roles, and talented individuals to join our team
Drop your CV at info@pvgpharmasciences.com
