Rishab Sharma
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Rishab Sharma Email & Phone Number

Senior Associate - Clinical Safety and Pharmacovigilance at Soterius, Inc.
Location: Gurugram, Haryana, India 5 work roles 3 schools
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Current company
Role
Senior Associate - Clinical Safety and Pharmacovigilance
Location
Gurugram, Haryana, India
Company size

Who is Rishab Sharma? Overview

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Rishab Sharma is listed as Senior Associate - Clinical Safety and Pharmacovigilance at Soterius, Inc., a company with 22 employees, based in Gurugram, Haryana, India. AeroLeads shows a matched LinkedIn profile for Rishab Sharma.

Rishab Sharma previously worked as Jr. Drug Safety Associate at Qinecsa Solutions and Drug Safety Associate at Ipca Laboratories Limited. Rishab Sharma holds Master Of Business Administration - Mba, Operations Management from Svkm'S Narsee Monjee Institute Of Management Studies (Nmims).

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Email format at Soterius, Inc.

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Soterius, Inc.

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Profile bio

About Rishab Sharma

I am highly skilled in Pharmacovigilance ICSR processing and management with assured quality.• Practical hands on assessment of case reports (ICSRS) for seriousness, causality and expectedness of adverse events.Well versed with Pharmacovigilance concepts (MedDRA coding and WHO-Drug Dictionary coding) and Reporting guidelines (FDA, ICH, EMEA, and other international guidelines).• Participated in the case review process applying a high standard of quality review to ensure sound medical safety data documentation.• Knowledge of Case Reciept, Case Triage, Case Narrative writing, performing Labelling/Listedness and Causality determination.• Basic understanding of Aggregate Reports (PSUR, PBRER, DSUR), sources of reporting and other terminologies used in ICSRS.• Understanding of Drug Development Process including Drug safety and different Phases of Clinical Trials.• Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements for clinical research and Pharmacovigilance.

Current workplace

Rishab Sharma's current company

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Soterius, Inc.
Soterius, Inc.
Senior Associate - Clinical Safety and Pharmacovigilance
princeton, new jersey, united states
Website
Employees
22
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5 roles

Rishab Sharma work experience

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Senior Associate - Clinical Safety And Pharmacovigilance

Current

New Delhi, Delhi, India

Oct 2022 - Present

Jr. Drug Safety Associate

Mysore, Karnataka, India

  • Data Entry:
  • Enter case data, including but not limited to General information, Reporter details, Patient details, Event details, seriousness, reported causality (when appropriate), medical history, and laboratory data as provided.
  • Code products specified as suspect or concomitant by the reporter using Company Drug Dictionary/WHO Drug Dictionary as needed, provide additional details as needed
  • Enter the narrative, as required, use a lead sentence as appropriate
  • Self-review AE report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards after completion of data entry.
  • Initiate follow-up activities to obtain additional information and clarification, as appropriate.
Mar 2021 - Sep 2022

Drug Safety Associate

Mumbai, Maharashtra, India

  • Monitoring of drug safety mailbox.
  • Preparation of company core datasheets
  • Updation of Products and Licenses in the safety database.
  • Safety data exchange agreement maintenance.
  • Reconciliation with Business Partners, Distributors, RBMs, Country Managers, andother vendors.
  • Acknowledging and acting on emails with Ipca Regulatory team.
Oct 2020 - Feb 2021

Intern

India

  • Working Knowledge of Clinical Trial Process, ICH-GCP, Budget Preparation, Site Initiation, and Site management activities ensuring Regulatory, ICH-GCP, and protocolCompliance.
  • ICF Designing, SOP Designing, CRF Designing, Data Cleaning, and Data Review Activities
  • Secondary Research, Review paper Writing, Protocol Designing.
  • Audio-Video recording of ICD process, Logistic Subject Follow-up
  • Antibiotic stewardship
  • Surgical prophylaxis
Sep 2019 - Feb 2020

Field Sales Officer

Arinna Lifesciences

Yamunanagar, Haryana

  • Increase product awareness, answer queries and provide advice.
  • Introduce new products.
  • Maintain a relationship with the customers.
  • Monitoring competitor and product activity.
  • The main responsibility is to track product availability assigned territory.
Jan 2018 - Sep 2019
Team & coworkers

Colleagues at Soterius, Inc.

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3 education records

Rishab Sharma education

Post Graduation Diploma In Pharmacovigilance And Cdm, Clinical Research And Pharmacovigilance

Medanta Institute Of Education And Research

Bachelor Of Pharmacy - Bpharm, Pharmacy

Pundit Bhagwat Dayal Sharma University Of Health Sciences
FAQ

Frequently asked questions about Rishab Sharma

Quick answers generated from the profile data available on this page.

What company does Rishab Sharma work for?

Rishab Sharma works for Soterius, Inc..

What is Rishab Sharma's role at Soterius, Inc.?

Rishab Sharma is listed as Senior Associate - Clinical Safety and Pharmacovigilance at Soterius, Inc..

Where is Rishab Sharma based?

Rishab Sharma is based in Gurugram, Haryana, India while working with Soterius, Inc..

What companies has Rishab Sharma worked for?

Rishab Sharma has worked for Soterius, Inc., Qinecsa Solutions, Ipca Laboratories Limited, Medanta, and Arinna Lifesciences.

Who are Rishab Sharma's colleagues at Soterius, Inc.?

Rishab Sharma's colleagues at Soterius, Inc. include Shubham Jassal, Neeraj Singh Rawat, Tanvi Chaturvedi, Api Singh, and Ravi Gaikwad.

How can I contact Rishab Sharma?

You can use AeroLeads to view verified contact signals for Rishab Sharma at Soterius, Inc., including work email, phone, and LinkedIn data when available.

What schools did Rishab Sharma attend?

Rishab Sharma holds Master Of Business Administration - Mba, Operations Management from Svkm'S Narsee Monjee Institute Of Management Studies (Nmims).

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