Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Nigeeth Mukundan

Kannur

Summary

A passionate Pharmacovigilance professional with 5 years and 4 months of proven experience in leadership activities, safety submission and case processing. Seeking the role of senior designation to exhibit communication, leadership and interpersonal skills in the best interest of the organization.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Drug Safety Specialist

Parexel International
12.2021 - 06.2023
  • Effectively led safety reporting part of multiple clinical trial studies
  • Performed submission of expedited Clinical Trial reports to Health Authorities, Ethics Committees, Investigators and business partners
  • Involved in exchange of Post Marketing (PM) reports (XML/CIOMS) to partners on behalf of client for regulatory reporting
  • Experienced in Argus database 8.1 for triaging and pulling applicable reports for regulatory reporting for post marketing and clinical trial studies
  • Participated in submissions of periodic reports (DSUR, 6 MLL and 3 MLL etc) to all applicable destinations according to latest regulatory reporting regulations
  • Hands on experience on submission of safety reports via FDA gateway, EV web, MHRA ICSR portal, CESP and various other portals
  • Preparation of regulatory requirement table and aggregate report assessment sheet for performing periodic report submission
  • Tracking of regulatory submissions and preparation of case filings for uploading in central filing tool (Veeva Vault/PMED)
  • Triaging of cases, approval monitoring and tracking of approvals for assigned studies
  • Sharing of monthly matrix, reporting requirement table and monthly and quarterly reconciliations to client and applicable recipients
  • Conducted quality checking various safety activities including data entry
  • Submission of safety reports to investigators via ISIS (International Safety Information System)
  • Knowledge of and ability to interpret and apply global safety regulations using International Safety Reporting Repository
  • Supported inspections and audits, ensuring compliance with all relevant regulations and guidelines
  • Provided safety training to internal staff to enhance awareness and compliance.

Senior Drug Safety Associate

Bioclinica
05.2020 - 06.2021
  • Mysuru (Product Safety Surveillance and Reporting), Hands on experience on case processing of individual case safety reports (ICSRs)–vaccine, spontaneous, literature, legal and special case scenarios (off label use, medication error, overdose) into the Argus safety database 8.2.1
  • Assessing case validity, evaluation of initial, follow-up information of individual adverse event case reports onto the safety database, using data interpretation, coding and writing skills in accordance with the instructions associated SOPs to ensure consistency of case entry, review with high data quality standards
  • Evaluation of adverse events seriousness and its listedness (CDS, IB, SPC, USPI)
  • Writing a detailed medically oriented description of the events in the form of safety narrative and checking the completeness and accuracy of the data entered in the various fields.

Drug Safety Associate

Icon Plc
10.2017 - 05.2020
  • Preparation of regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Investigators and business partners
  • Handling of SUSARs and SAEs routed to regulatory report workflow in the Argus 8.1.2 database
  • Triaging reportability of all Individual case safety reports, unblinding the expedited reports
  • Expertise in Argus database: Involved in scheduling, generating, approving and submitting final reports (CIOMS/MedWatch/XML) of all adverse events
  • Involved in locking and unlocking of cases and unsubmitting the reports (Workflow manager access) in Argus database, Argus E2B submissions
  • Experience in automated scheduling of regulatory reports in Argus safety database
  • Involved in peer reviewer of packages and submission of cases via fax and mail expert system (FAME) and perform its QC
  • Ensure all the relevant documents are filed in appropriate case folders in compliance with regulatory reporting requirements for safety reporting in clinical trials
  • Submission of post marketing cases using FDA Safety Reporting Portal and clinical trial cases using safety reporting system
  • Performed Eudralink submission of DSUR using EMA web portal
  • Involved in providing trainings to new team members on case processing and to clients on safety reporting processes
  • Safety reporting lead of post marketing and clinical trial studies
  • Involved in setup of the project in safety reporting system
  • Creation and maintenance of training matrix, project specific procedures and project specific documents (IB/Protocol/CP), reviewing the study specific procedures, approval letters and cover letters
  • Involved in reviewing the project contracts (costings of Safety Reporting Group portion) with senior management
  • Performed sending monthly compliance reports to clients and reconciliation activities of assigned projects.

Research Intern

Hindustan Latex Limited
12.2016 - 09.2017

Education

Master’s Degree - Pharmacy (Pharmacology)

Kerala University of Health Sciences
09.2016

Skills

  • Pharmacovigilance
  • Leadership
  • Project Management Skills
  • Case Processing
  • Safety Reporting (Individual/Aggregate)
  • Global Safety Regulations
  • Argus Database
  • Safety Reporting Repository
  • Standard Operating Procedures (SOPs)

Certification

Pharmacovigilance Global Safety Regulations Leadership Argus Database Project Management Skills Safety Reporting Repository Case Processing Standard Operating Procedures (SOPs) Safety Reporting (Individual/Aggregate) PUBLICATION Prevalence and use of research medication in stable asthma patients, Worlds Journal of Pharmaceutical Research, 3(3), pp. 4094 – 4097; 2014.

Timeline

Drug Safety Specialist

Parexel International
12.2021 - 06.2023

Senior Drug Safety Associate

Bioclinica
05.2020 - 06.2021

Drug Safety Associate

Icon Plc
10.2017 - 05.2020

Research Intern

Hindustan Latex Limited
12.2016 - 09.2017

Master’s Degree - Pharmacy (Pharmacology)

Kerala University of Health Sciences

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