Summary
Overview
Work History
Education
Skills
Languages
Job Inclination
Personal Information
Certification
Languages
Timeline
Generic
SANDEEP KUMAR

SANDEEP KUMAR

BADARPUR

Summary

Motivated professional with several years of experience juggling multiple priorities to keep company running smoothly. Communicative team leader possessing outstanding time management and documentation abilities. Polished in overseeing employee performance and guiding and motivating new talent.

Overview

11
11
years of professional experience
1
1
Certification

Work History

Assistant Manager

Cencora, Pharmalex
Noida
02.2025 - Current
  • Facilitated cross-departmental communication to enhance collaboration and operational efficiency.
  • Implemented process improvements that significantly streamlined daily workflows.
  • Analyzed data to support strategic initiatives and informed decision-making processes.
  • Ensured compliance with safety regulations and company policies at all times.
  • Reviewed completed work for consistency, quality, and adherence to standards.
  • Processed ICSR cases while conducting quality reviews on BPI Pheda database.
  • Guided junior staff on tasks, projects, and objectives for professional development.

Compliance Team Lead

Soterius Life Science
Delhi
10.2024 - 02.2025
  • Ensured compliance in ICSR case processing within Pharmacovigilance projects.
  • Developed compliance reports and quality data aligned with KPIs, shared with clients per SLA timelines.
  • Trained team on ICSR case processing to improve efficiency and accuracy.
  • Created Excel trackers for case status reconciliation, enhancing communication with clients.

Safety and Pharmacovigilance Specialist 2

Syneos Health Limited
Gurugram
12.2021 - 09.2024
  • Quality control of ICSRs in Argus for case processing of spontaneous, patient support program, market research program, non-interventional study, license partner, pregnancy, literature, regulatory authority, drug device combination products and other study cases for antiepileptic drugs, biological drugs for psoriasis, psoriatic arthropathy, osteoporosis, myasthenia gravis, diabetic drug domain.
  • Served as subject matter expert, offering guidance and resolving queries for case processing team.
  • Mentored new associates on Argus case processing conventions in accordance with client SOP guidelines.
  • Processed EMA-CP ICSRs for regulatory authority on EVWEB
  • Detected and merged duplicate ICSRs, creating a comprehensive master file for accurate record-keeping.

Data Analyst

Cognizant Limited
Gurugram
07.2021 - 11.2021
  • Conducted thorough quality reviews of ICSR cases on Argus database
  • Maintained pharmacovigilance databases to ensure accurate data entry.
  • Reviewed adverse event reports for completeness and accuracy.

Pharmacovigilance Associate

APCER Life Science Ltd
New Delhi
04.2015 - 11.2016
  • Conducted literature research and data analysis for signal detection and Periodic Safety Update Reports.
  • Monitored literature on Embase and PubMed, identifying valid ICSRs for compliance maintenance.
  • Entered data into the Art 57 database (XEVMPD) for EU clients, ensuring accuracy.
  • Updated Summary of Product Characteristics and managed product withdrawals in the XEVMPD database.

Data Migration Officer

Wipro
Delhi
10.2014 - 02.2015
  • Executed data entry for ICSR case processing within Argus safety database.
  • Entered patient details and performed product coding using CDD and WHO dictionary.
  • Applied Medra drug dictionary for precise event coding and causality assessment.
  • Composed narrative reports and developed detailed case summaries.

Education

M. Pharm - Pharmaceutics

IEC College of Engineering And Technology
Greater Noida
07-2014

B. Pharm -

KIET School of Pharmacy
Ghaziabad
07-2011

D. Pharm - Pharmacy

Delhi Institute of Pharmaceutical Science & Research
Delhi
07-2008

Senior Secondary -

Kendriya Vidyalaya
New Delhi
07-2005

Higher secondary -

Govt. Boys Sec. School
New Delhi
05-2003

Skills

  • 10 years of work experience in pharmacovigilance
  • Project oversight
  • Client relations management
  • Communication effectiveness
  • Data analysis and compliance
  • Mentorship and training
  • Regulatory adherence
  • Cross-departmental collaboration
  • Quality assurance
  • Pharmacovigilance databases (Argus, BPI Pheda, EVWEB, Noesis, DD client, XEVMPD)

Languages

  • English
  • Hindi

Job Inclination

  • Pharmacovigilance
  • Data analysis
  • Secondary research
  • Life sciences
  • Drug regulatory

Personal Information

  • Notice Period: 1 month
  • DOB: May 23, 1987
  • Nationality: Indian
  • Marital Status: Married

Certification

  • Gpat qualified
  • Registered pharmacist

Languages

Hindi
First Language
English
Advanced (C1)
C1

Timeline

Assistant Manager

Cencora, Pharmalex
02.2025 - Current

Compliance Team Lead

Soterius Life Science
10.2024 - 02.2025

Safety and Pharmacovigilance Specialist 2

Syneos Health Limited
12.2021 - 09.2024

Data Analyst

Cognizant Limited
07.2021 - 11.2021

Pharmacovigilance Associate

APCER Life Science Ltd
04.2015 - 11.2016

Data Migration Officer

Wipro
10.2014 - 02.2015

M. Pharm - Pharmaceutics

IEC College of Engineering And Technology

B. Pharm -

KIET School of Pharmacy

D. Pharm - Pharmacy

Delhi Institute of Pharmaceutical Science & Research

Senior Secondary -

Kendriya Vidyalaya

Higher secondary -

Govt. Boys Sec. School

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SANDEEP KUMAR