A hybrid approach towards signal management in Pharmacovigilance

Signal management in pharmacovigilance is a process of multiple activities evaluating risks associated with a particular medicinal product, or whether known risks associated with a particular drug have changed in frequency or severity. The signal management process follows a systematic approach: Signal detection, Signal Validation Signal prioritization, Signal assessment, Recommendation for action, and finally Exchange of information. Signal detection is the most vital part of signal management. Traditional methods include usage of solitary algorithms which are not accompanied by additional features of qualitative data mining resulting in mediocre performance. TCS scientists devised a hybrid approach in which the algorithm is fueled to assess a signal and also manage it for effective grading based on a qualitative approach.

In this paper we provide a comprehensive and detailed description of this hybrid approach.

Dr. Alejandra Guerchicoff

Dr. Alejandra Guerchicoff is a PhD in molecular genetics with a post-doctoral training in molecular cardiology. She is working as an Industry Advisor for TCS ADD platform with the Life Sciences unit at Tata Consultancy Services (TCS). Dr. Guerchicoff possesses a rich experience of more than 20 years in the domain of clinical research and post-marketing pharmacovigilance, for medical devices, drugs, combination products, gene and cell therapy, and software as medical device products.

Ashutosh Pachisia

Ashutosh Pachisia is a Data Scientist at Tata Consultancy Services (TCS). With nearly half a decade of experience in IT. He has a rich experience leading large complex programs and driving key initiatives for TCS Healthcare.

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A hybrid approach towards signal management in PV

Dr. Alejandra Guerchicoff

Industry Leader – TCS ADD Safety, TCS

Ashutosh Pachisia

Data Scientist, TCS ADD Platforms, TCS

About the authors

Dr. Alejandra Guerchicoff

Ashutosh Pachisia

Transformation starts here

TCS is here to make a difference through technology.

We’re in it for good, driving positive change for the benefit of all.

Recent News

Extraordinary expertise leads to remarkable results.

Want to be a global change-maker? Join our team.

TCS works hand in hand with world-leading investors.

TCS is here to make a difference through technology.

We’re in it for good, driving positive change for the benefit of all.

Recent News

Extraordinary expertise leads to remarkable results.

Want to be a global change-maker? Join our team.

TCS works hand in hand with world-leading investors.

About the authors

Dr. Alejandra Guerchicoff

Ashutosh Pachisia

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