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.
Senior Pharmacovigilance Physician
Pharsafer Associated Ltd.
Since January 2018
Part-time
London
United Kingdom
- I have been working part-time with Pharsafer Associates while working from home and carrying out similar duties as when I worked from them full-time in London between April 2016 till February 2017.
I took a gap from work due to Personal reasons and re-joined Pharsafer again in Jan 2018 and since then been working with them. - My work profile is as similar to my previous work with Pharsafer
- Recently successfully managed a Medical Review work as a Project Manager on behalf of Pharsafer; for a company called GVI, based in Canada.
Drug Safety Physician
Pharsafer Associates Ltd.
April 2016
to February 2017
Full-time
London
United Kingdom
- The 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.
- Closely collaborate with Safety Operations for seamless PV processes.
- 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.
- Develop and maintain on-going relationships with external key opinion leaders (KOLs), healthcare professionals, government authorities, funding bodies and other entities.
- Expertise in Adverse Event (AE) and Serious Adverse Event (SAE) case medical evaluation including cases coming from post-marketing 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.
- Write/Participate in writing/reviewing Safety Reports (PSURs, DSURs, Clinical Overview Benefit-Risk Reports, IB, ICF forms, Annual Reports)
- Perform review of aggregate line listing signal/trend detection
- Provide Medical safety input for investigator's, brochures, submissions
- Draft Analysis of Similar Events for SUSARs and aggregate reports as necessary, review and approve investigator safety letters
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.
Assistant Doctor
Saaol Heart Center
January 2014
to June 2014
Full-time
New Delhi
India
- Checked patients and prescribed them pharmaceuticals or referred them to other specialists.
- Diagnosed, monitored treatments and carried out assessments of patients.
- Performing Non- invasive Cardio therapy ยท Carried out campaigns for prevention and detection of diseases.
- Maintained the confidentiality of patient information as per guidelines of the state.
- Performed regular health inspections to track progress of patient's health.
Resident Medical Officer - RMO
Tarawati Super Speciality Hospital
September 2013
to December 2013
Full-time
Saharanpur
India
- Complete a brief admission examination on each patient when appropriate and document clinical findings.
- Attend ward rounds with consulting staff, as required, and be available to discuss patient treatment plans.
- Provide a 24-hour medical service within the hospital on an on-call basis permanently.
- Inform admitting consultants of changes in medical condition of patients and of relevant action taken.
- Follow the instructions of consultants for their specific regime for each individual patient.
- Perform clinical procedures as requested by consultant medical staff and nursing staff.
- Initiate and alter in-patient prescriptions at consultant's request.
- Write up "to take home prescriptions" for patients as required.
- To be completely familiar with emergency equipment.
- To dispense drugs with senior nurse on duty in absence of pharmacist.
- To record all treatments performed in patient notes.
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Clinical Pharmacology
Advanced
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Pharmacology
Advanced
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MedDRA
Advanced
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Clinical Data Management
Advanced
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ARGUS
Advanced
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Database Specialist ARISg
Advanced
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Database Specialist ARGUS
Advanced
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Medicine
Advanced
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Medical Education
Expert
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Medical Terminology
Advanced
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Medical Devices
Advanced
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Internal Medicine
Advanced
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Medical-Surgical
Advanced
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IVF
Advanced
