Dr. Swati Gupta
Senior Pharmacovigilance Physician
37 years old
Driving License
London (WD19 6HJ) United Kingdom
Employed
Just looking around
Senior Pharmacovigilance Physician who excels at analysing, prioritising and completing tasks in a professional manner.
Strong organizational, technical and analytical skills. I have always envisaged working closely with people in an intellectually stimulating environment and in my opinion, a career in medicine is one of the best ways to achieve this, blending the analytical thinking of a scientist with the compassion of a carer.
Seeking a fulfilling position in the Pharmacovigilance industry as Pharmacovigilance / Drug Safety Officer that offers growth opportunities and allows me to utilize my leadership skills and experience.
My goal is to collaborate with the team I work with and further enhance the company's success and reputation. To seek challenging assignment and responsibility, with an opportunity for growth and career advancement as successful achievements.
Strong organizational, technical and analytical skills. I have always envisaged working closely with people in an intellectually stimulating environment and in my opinion, a career in medicine is one of the best ways to achieve this, blending the analytical thinking of a scientist with the compassion of a carer.
Seeking a fulfilling position in the Pharmacovigilance industry as Pharmacovigilance / Drug Safety Officer that offers growth opportunities and allows me to utilize my leadership skills and experience.
My goal is to collaborate with the team I work with and further enhance the company's success and reputation. To seek challenging assignment and responsibility, with an opportunity for growth and career advancement as successful achievements.
Pharmacovigilance Physician
Client Associated Businesses, Inc.
August 2014
to February 2016
Full-time
New Delhi
India
- The Pharmacovigilance / Drug Safety Physician is responsible for safety surveillance of medical products. This implies medical assessment of adverse event reports, detecting and assessing risks and proposing risk mitigating activities. With that aim, the Drug Safety Physician represents the medical safety function in relevant business processes and committees, both in clinical development and in the postmarketing space, to ensure consistency of safety focus, methods and communications.
- Medically review individual adverse event reports, both from clinical trials or post-marketing, for seriousness, expectedness and causality.
- Identify and assess potential safety signals for Ironwood products, and communicate to the Safety Review Committee.
- Closely collaborate with Safety Operations for seamless PV processes.
- Collaborate with clinical trial directors for safety monitoring.
- Provide medical input to training materials and delivery of events to ensure accuracy of content.
- Prepares the medical and scientific evidence together with a sound business case to communicate the benefits of product portfolio to the market and manage advisory boards effectively.
- Contributes to the process of regulatory review and approval across the region
- Provide advice across the company on PVG, medical, regulatory and clinical matters and activities relating to assigned product portfolio.
- Advise clinical trials teams relating to the most high impact and complex cases.
- Expertise in Adverse Event (AE) and Serious Adverse Event (SAE) case medical evaluation including cases coming from postmarketing sources, cases in litigation, and clinical trial cases for investigational products for oncology, cardiovascular, endocrinology, pain and inflammation, osteoporosis, nicotine replacement therapy, and other indications.
- Led projects supporting various pharmaceutical products in market. Achieved and maintained high level of client satisfaction throughout assigned projects.
- Proven ability to liaise effectively with business professionals as well as scientists and colleagues in the industry. Good mentor and trainer.
Company Description
Client Associated Businesses, Inc. (CAB) is a clinical services company specializing in providing biometric support to the pharmaceutical, biotechnology, medical device Industries and other organizations such as contract research organizations (CROs). Our team of highly experienced data managers, database programmers, pharmacovigilance managers and IT technical consultants can be provided in custom tailored resourcing and production support models to meet a clients specific staffing needs
