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.
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
Company Description
PharSafer® is a specialist Global CRO focusing on Pharmacovigilance & Medical Services. Formed in 2002 and Headquartered in the UK. It acta as an complete outsourced Pharmacovigilance and Medical Services Department/Organisation, performing all of the activities expected of an Pharmacovigilance and Medical Information teams.
It provides services for:
Pharsafer worked as an Associate with my previous Employer Client Associated Businesses, Inc. INDIA. I moved to UK following my marriage and joined them as a Drug Safety Officer. So my job responsibilities were nearly similar at both the places.
It provides services for:
- Full case processing and expedited reporting globally
- Aggregate report writing, such as, DSURs, PSURs/PBRERs and PADERs
- Risk Management Plan (RMP) writing and management
- Safety review/Signal Detection and Benefit-Risk assessments
- EU QP PV Services
- Medical services
- Audits
Pharsafer worked as an Associate with my previous Employer Client Associated Businesses, Inc. INDIA. I moved to UK following my marriage and joined them as a Drug Safety Officer. So my job responsibilities were nearly similar at both the places.
