Summary
Overview
Work History
Education
Skills
Languages
Accomplishments
Affiliations
Certification
Timeline
Generic
NIHARIKA AS

NIHARIKA AS

BENGALURU

Summary

Detail-oriented and experienced Drug Safety Associate with a strong background in pharmacovigilance. Adept at adverse event reporting and regulatory compliance, ensuring patient safety and product quality. Seeking to contribute to a dynamic pharmaceutical company.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Drug Safety Associate - I

Novo Nordisk
BENGALURU
12.2022 - Current
  • Handled case processing and adverse event reporting in compliance with global regulatory requirements (FDA, EMA, etc.)
  • Identification of potential safety concerns and trends.
  • Participated in safety data exchange agreements and risk management activities.
  • Explored and addressed potential safety risks arising from product quality or manufacturing-related issues.
  • Independent decision making regarding evaluating the submission of adverse event reports.
  • Collaborated with cross-functional teams to ensure accurate and timely submission of safety reports.

Summer Intern

Dr.Reddy's Laboratories
Baddi
04.2022 - 09.2022
  • Worked briefly across various production areas including oral solid dosage, semisolids, and injectables.
  • Achieved proficiency in preparing multiple OOT and OOS investigation reports for oral solid dosage forms, along with conducting a detailed study on the VSM of an oral dosage product using QC tools.

Internship Student

BioPlus Life Sciences Private Limited
BENGALURU
10.2020 - 11.2020
  • Performed various roles across departments including Production Unit, Quality Assurance Department, Quality Control Department, and Analytical Laboratory.

Education

Master of Pharmacy - Pharmaceutics

Amrita School of Pharmacy, Amrita Vishwavidyapeeth
Kochi
07-2022

Bachelor of Pharmacy - Pharmacy

Acharya & BM Reddy College of Pharmacy
Bengaluru
10-2020

High School Education -

Vidya Jyothi Pre-University College
Kolar
06-2016

Secondary School Education (10th Grade) -

Kendriya Vidyalaya
04-2014

Skills

  • Medical terminology proficiency
  • Proficient in safety database systems (eg, Argus, SIMS, CCGloW)
  • Basic knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety (FDA, EMA)
  • Time management abilities
  • Problem-solving capabilities
  • Risk management understanding
  • Conflict resolution abilities
  • Analytical and Critical Thinking
  • Problem-solving aptitude
  • Interpersonal Skills
  • Excellent Communication

Languages

English
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Telugu
Proficient (C2)
C2
Kannada
Proficient (C2)
C2
Malayalam
Upper Intermediate (B2)
B2
Tamil
Upper Intermediate (B2)
B2

Accomplishments

  • Have been a GEM (Going Extra Mile) Awardee for Q1 and Q2, 2024

Affiliations

  • Singing: Actively participated and won accolades at several music events. Proficient in various musical styles including classical and contemporary. Passionate about the art of music and its role in personal development and creativity.
  • Traveling: Enthusiastic traveler with a keen interest in exploring diverse cultures, history, and cuisines.

Certification

  • Actively engaged in and attended multiple LearnIt courses, including Diabetes, Obesity, and Other Therapeutic Areas Portfolio Training, as well as Rare Disease Portfolio Training.

Timeline

Drug Safety Associate - I

Novo Nordisk
12.2022 - Current

Summer Intern

Dr.Reddy's Laboratories
04.2022 - 09.2022

Internship Student

BioPlus Life Sciences Private Limited
10.2020 - 11.2020

Master of Pharmacy - Pharmaceutics

Amrita School of Pharmacy, Amrita Vishwavidyapeeth

Bachelor of Pharmacy - Pharmacy

Acharya & BM Reddy College of Pharmacy

High School Education -

Vidya Jyothi Pre-University College

Secondary School Education (10th Grade) -

Kendriya Vidyalaya

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