Summary
Overview
Work History
Education
Skills
Accomplishments
Work Availability
Licenses and Certifications
Timeline
Generic

Somya Gupta

Operation Specialist
Bengaluru,Karnataka

Summary

Currently working as Operations Specialist in Lifecycle Safety organization at IQVIA. I Joined IQVIA in 2016 and served in legal team.

My current responsibilities are to perform duplicate search, data entry, triage of incoming cases to determine seriousness for prioritization, capturing relevant medical terminology, coding products, generating queries pertinent to the case, and other activities as per process.

I have completed M.Pharm in Pharmaceutics and secured 1st rank in my university and completed B.Pharm (secured 7th rank all over UP) from Uttar Pradesh Technical University.

Prior to joining IQVIA, I have worked as Pharmacovigilance Associate in WIPRO LTD as a Case Processor and Quality Review of spontaneous and literature cases.

My aim is to secure a challenging position where I can effectively utilize my skills and functionalities with full dedication along with that a keen learner and to explore new areas.

Overview

8
8
years of post-secondary education
5
5
years of professional experience

Work History

Operation Specialist

IQVIA
BENGALURU, Karnataka
10.2018 - Current
  • Ensure all required training and on job certification are executed in a timely fashion and documented
  • Process ICSRs according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements as directed
  • Perform duplicate search, data entry, capturing relevant medical terminology, coding products, generating queries pertinent to the case, and other activities as per process
  • Perform quality review of receipt items as per applicable SOPs
  • Ensure project activities are completed as per requirements related to quality and timelines
  • Assist with other activities (Example: requesting translations, reconciliations, mailbox management, PQC referral etc.), as required
  • Backup of Manager in sending workflow status to the clients, allocation of cases/receipts to the associate
  • Part of Subject Matter Expert (SME) related to the Adverse Events field and identify areas of improvement and do the needful
  • Assisting with other additional activities understanding the error and resolving the queries for identified activities
  • Address emails from different stakeholders and customers supporting ICSR activities within timelines and seek clarifications where appropriate (Local Safety Officer (LSO), Customer POCs etc.)
  • Adhere to quality standards in achieving project and customer deliverables
  • Understand relevant safety implications regarding contracts with operating companies and/or marketing partners
  • Participate in Audits & Inspections, as required
  • Participate in continuous improvement of project specific processes and procedures by identifying and implementing efficiencies in workflow and/or case processing and bring them to the attention of Manager
  • Contribute to process improvements
  • Build a positive, collaborative team environment, provide training and mentoring for less experienced team members
  • Attend project team meetings and provide feedback on any challenges/issues or successes
  • Liaise with various stakeholders in relation to details on day to day process of cases, as required
  • Collaborate with management to help achieve operational goals
  • Perform other duties as assigned

Safety Associate Trainee, I and II

IQVIA
BENGALURU, Karnataka
10.2016 - 10.2018
  • Key Responsibilities: Initial Receipt, Database searches as necessary
  • Registry and triage of incoming cases to determine seriousness for prioritization of daily workflow completion of literature searches as necessary completion of case processing (case data entry, labeling, approval numbers, manual coding, narrative writing) and quality review clarification of unclear or illegible information from the local safety officer or cal centre and customer communication as per the project requirement
  • Discuss source documents, coding conventions and ad-hoc queries with pharmacovigilance physician
  • Completion of protocol request forms as necessary preparation of deviation memos as necessary request deletion/admin edit request as necessary Single case unblinding other case processing related activities

Pharmacovigilance Associate

WIPRO LTD
10.2015 - 03.2016
  • Key Responsibilities: case processing, quality review of spontaneous and literature cases
  • Data entry of adverse events reporting (AE) from source docs, including patient demographic data, suspect and concomitants, narrative selection and event assessment, dechallenge and rechallenge, e2b validation

Drug Regulatory Affairs Trainee

ARBRO PHARMACEUTICALS
New Delhi, New Delhi
06.2015 - 09.2015
  • Key Responsibilities: New regulatory norms in Afghanistan and its compilation for registration of drugs
  • Department Specific Experience Department: Lifecycle Safety Category Experience Argus

Education

M.Pharm - Pharmaceutical Sciences

Galgotias University
Gr. Noida
08.2013 - 06.2015

B.Pharm - A Complete Study of Pharmacy

Kanpur Institute of Technology
Kanpur
08.2009 - 06.2013

Class 12th PCB -

St. Joseph's Sr. Sec. School
Kanpur
04.2008 - 03.2009

Class 10th -

St. Joseph's Sr. Sec. School
Kanpur
03.2006 - 03.2007

Skills

    Sceptre, ARISg

undefined

Accomplishments

  • Received Bravo in the year of 2018, for the highest productivity in the legal team, 2018
  • Received applause in the year of 2018 as a appreciation, 2018
  • Received Bravo in the year of 2017 for the good work in the quintiles, 2017
  • Secured 1st rank in Master of Pharmacy (M.Pharm) in session 2013-2015
  • Stood 7th rank in UPTU and won silver medal along with Rs 20,000 as Merit holder in 2013
  • Stood 1st for 4 consecutive years in Bachelor of Pharmacy (B.Pharm) and won Gold medal along with Rs 10,000 each year
  • Qualified GPAT with 151 score and 3179 rank in 2013

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse

Licenses and Certifications

  • Participated in International Conference on "Global trends in Pharmaceutical and Clinical Practices" held on Teerthankar Mahaveer University, Moradabad, 2015
  • Drug License since 2015
  • Presented a poster on "EXTRACTION AND CHARACTERIZATION OF HIBISCUS ROSASINENSIS MUCILAGE AS PHARMACEUTICAL ADJUVANT” in "Interdisciplinary Research in Science & Technology" held on Lingaya's GVKS Institute of Management and Technology, Faridabad during academic session 2014-15
  • Presented a poster on "EXTRACTION AND CHARACTERIZATION OF CORDIA DICHOTOMA MUCILAGE AS PHARMACEUTICAL ADJUVANT" held on Teerthanker Mahaveer University, Moradabad (U.P.) during academic session 2014-15
  • One month training in production and quality control departments from Karnani Pharmaceuticals, Selaqui, Dehradun, 2012
  • Participated in National Seminar on "Current Challenges of Pharmacy Education & Research" held on Advance Group of Pharmacy Colleges, Kanpur, 2012
  • Presented a poster on "SAFTEY ISSUES AND HEALTH RISKS WITH HERABL MEDICINE" held on Advance College of Pharmacy, Kanpur during academic session 2011-12

Timeline

Operation Specialist

IQVIA
10.2018 - Current

Safety Associate Trainee, I and II

IQVIA
10.2016 - 10.2018

Pharmacovigilance Associate

WIPRO LTD
10.2015 - 03.2016

Drug Regulatory Affairs Trainee

ARBRO PHARMACEUTICALS
06.2015 - 09.2015

M.Pharm - Pharmaceutical Sciences

Galgotias University
08.2013 - 06.2015

B.Pharm - A Complete Study of Pharmacy

Kanpur Institute of Technology
08.2009 - 06.2013

Class 12th PCB -

St. Joseph's Sr. Sec. School
04.2008 - 03.2009

Class 10th -

St. Joseph's Sr. Sec. School
03.2006 - 03.2007

Similar Profiles

CREATE PROFILE
Somya GuptaOperation Specialist