Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Career break
Generic

Sneh Kashyap

East Windsor,NJ

Summary

A dedicated and results-oriented pharmacovigilance professional with around 5 years of experience in drug safety, adverse event reporting, and regulatory compliance. Proven expertise in managing and analyzing pharmacovigilance data, supporting clinical safety, and ensuring compliance with global regulatory standards. Experienced in leading teams and collaborating with cross-functional stakeholders to achieve operational excellence. Following a career break due to relocation and parenting, now highly motivated to apply extensive knowledge and experience to make valuable contributions within a dynamic pharmacovigilance team, driving excellence in drug safety and regulatory compliance.

Overview

5
5
years of professional experience
1
1
Certificate

Work History

Senior Pharmacovigilance Associate

Apcer Lifesciences
04.2017 - 09.2019
  • Oversight of collection, triage, and processing of adverse event (AE) reports from clinical trials and post-marketing sources.
  • Proficient in safety databases (e.g., Argus, Arisg) ensuring accurate data management and reporting.
  • Performed final quality checks and reviews of ICSR data for accuracy, completeness, and compliance with regulatory standards.
  • Ensured adherence to regulatory guidelines for clinical trial reporting, including timely submission of expedited reports (e.g., SUSARs) to health authorities.
  • Conducted thorough assessments of adverse event reports for seriousness, causality, and expectedness, utilizing established criteria and company guidelines.
  • Proactively ensure ICSR readiness for inclusion in individual and aggregate reports (i.e. PSURs, PADERs, DSURs).
  • Comprehensive knowledge of global pharmacovigilance regulations and guidelines (ICH-GCP, FDA, EMA), ensuring compliance in all aspects of adverse event reporting and safety monitoring.
  • Collaborated with safety physicians and clinical teams to evaluate relationship between drug exposure and reported adverse events.
  • Ensured accurate coding of medical terms using standardized dictionaries (e.g., MedDRA) and review coding performed by junior associates.
  • Maintained data integrity by addressing discrepancies and ensuring completeness of case narratives.
  • Provided mentorship and training to junior pharmacovigilance associates on ICSR processing, regulatory compliance, and pharmacovigilance best practices.
  • Acted as Subject Matter Expert (SME) for New Team Initiation and Training to enhance team knowledge and skills in clinical trial safety reporting.
  • Strong analytical and problem-solving skills for identifying and resolving safety issues.
  • Identified opportunities for process improvements and contribute to development of enhanced ICSR processing workflows.
  • Experience in developing and implementing SOPs and other process improvement initiatives.
  • Proven ability to work independently and as part of a team to achieve project goals and deadlines.
  • Strong attention to detail and commitment to data accuracy and integrity.
  • Enhanced patient safety by meticulously reviewing and analyzing adverse event reports.
  • Improved data quality for regulatory submissions by conducting thorough case assessments in compliance with FDA guidelines.
  • Monitored deliverables for quality and adherence to regulatory reporting timelines.

Pharmacovigilance Associate

APCER Life Sciences
11.2014 - 03.2017
  • Performed duplicate case checks, book-in and triaging for cases in Argus safety database.
  • Processed ICSRs from spontaneous reports, literature, clinical trials, ensuring accurate and timely data entry.
  • Accurately captured adverse event details, including medical coding (using MedDRA) and creation of comprehensive case narratives.
  • Evaluated cases for seriousness, expectedness, and causality, ensuring compliance with global regulatory requirements.
  • Submitted expedited report( SUSARs) to regulatory authorities, adhering to strict timelines.
  • Performed thorough quality checks on case data, identifying discrepancies and ensuring adherence to standard operating procedures (SOPs).
  • Liaised with investigators and clinical sites to gather additional information and follow-up on incomplete reports to ensure data completeness.
  • Worked cross-functionally with clinical, data management, and regulatory teams to manage safety data and ensure compliance.
  • Followed company SOPs and global pharmacovigilance regulations by completing all required training in timely manner.
  • Provided training and mentorship to new team members on case processing workflows and regulatory standards.

Education

Master of Pharmacy - Medicinal And Pharmaceutical Chemistry

Amity University
Noida, India
10.2014

Bachelor of Pharmacy -

Maharishi Markendeshwar University
Mullana (Ambala), India
05.2012

Skills

  • Adverse event reporting
  • Safety database systems (eg, Argus, Arisg)
  • Medical coding (MedDRA)
  • Regulatory compliance (eg, ICH-GCP, FDA, EMA)
  • Case processing and quality control
  • Drug safety expertise
  • Continuous learning mindset
  • Problem-solving abilities
  • Attention to Detail
  • Task Prioritization
  • Teamwork and Collaboration
  • Multitasking
  • Excellent Communication

Certification

[Certificate Course in Pharmacovigilance Aggregate Reporting] [Udemy] [2024 May]

[Practical course on Pharmacovigilance Aggregate Reports] [Udemy] [2024 June]

[Signal Detection and Management in Pharmacovigilance] [Udemy] [2024 Oct]

[Pharmacovigilance Risk Management Plan: Step by Step Guide] [Udemy] [2024 Oct]

Languages

English
Full Professional
Hindi
Native or Bilingual

Timeline

Senior Pharmacovigilance Associate

Apcer Lifesciences
04.2017 - 09.2019

Pharmacovigilance Associate

APCER Life Sciences
11.2014 - 03.2017

Master of Pharmacy - Medicinal And Pharmaceutical Chemistry

Amity University

Bachelor of Pharmacy -

Maharishi Markendeshwar University

Career break

Career break due to relocation and to focus on parenting responsibilities.

Actively staying updated on latest trends and developments in pharmacovigilance and by training in basics of advanced PV skills such as aggregate reporting, REMS, and signal detection.

 

Similar Profiles

CREATE PROFILE
Sneh Kashyap