Summary
Overview
Work History
Education
Skills
Timeline
Generic

Nidhi Gaikwad

Roseland,NJ

Summary

Pharmacovigilance professional with Bachelors in Dental Surgery and 12 years of experience in both clinical and post-marketing trials. Operational expertise includes people management, project management, process improvements, business analysis, KPI quality metrics.

Overview

17
17
years of professional experience

Work History

Supervisor, Pharmacovigilance

ICON
06.2021 - Current
  • Supervises global teams of Pharmacovigilance (PV) Associates, serves as the drug safety point of contact for internal and external stakeholders.
  • Set up process for Adverse event reporting and processing and expedited safety reporting for assigned project/product. Develops SAE form, Pregnancy report form , e-CRF review as per project protocols.
  • Develops and conducts training sessions for team members and training for clinical sites for Adverse event reporting process during investigator meetings.
  • Oversees adverse event (AE) processing workflow and global submission of expedited safety reports, periodic & Aggregate safety reports to health authorities, central ethics committees and Investigators.
  • Collaborates with Clinical Operations, project management, Regulatory Affairs, and Medical team for project set up.
  • Reviews safety planning documents (e.g. Safety Management Plans, SAE Reconciliation Plans, Literature Search Plans, DSURs, Global Benefit Risk Assessment Statement, protocol ).
  • Supports safety scientist in safety data review and signal detection activities and quality control during the generation of Aggregated Safety Reports.
  • Identifies operational/financial risks in relation to the assigned service areas and collaborates with project manager on resolution plans for risks to effort, quality, scope and budgets for assigned project.
  • Supervises 3 US based and 2 Canada based PV associates. Communicates goals and expectations to ensure direct reports understand their responsibilities. Performs midyear & year end performance review of direct reports.
  • Identifies and implements process improvements through review of SOPs, processes; recommend improvement plans to senior management. participates in departmental process and system improvement initiatives.
  • Contributes to business development efforts in Drug Safety, including presenting safety services at bid defense meetings, reviewing RFP/proposals/budget grid.
  • Participate and support internal audits & external audits. Participated in sponsor audits, FDA audit, MHRA inspection, PMDA audits.

Senior Drug Safety Associate

ICON
05.2018 - 06.2021
  • Intracompany transfer from Singapore to USA in April-2019.
  • Served as PV project Lead on multiple global studies and coordinated large or global teams of PV associates and safety data coordinators served as the drug safety point of contact for study teams on project level.
  • Effectively mentored junior/new hired PV associates on Adverse event processing and safety reporting tasks.
  • Participated in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings.
  • Conducted literature surveillance and supported for analysis and quality control during the generation of Aggregated Safety Reports.
  • Safety database configuration and corresponding entry guidelines, included assurance of quality of data following established quality control process.
  • Participated in clinical database programming and performed User acceptance test for EDC during study start up.
  • Supported audits and inspections as required for the assigned projects.
  • Facilitated internal/external (sponsor, client, and project team meetings) meetings; managed various projects assigned simultaneously; developed and revised timeline and guided team.
  • Contributed to business development efforts in Drug Safety, including presenting safety services at bid defense meetings.
  • Reported project status (including monthly metrics) to project/functional management within agreed upon timelines.

Drug Safety Associate 2

PRA Health Sciences
10.2013 - 03.2018
  • Performed safety case processing tasks including Adverse event collection, tracking in safety database, Data Entry, MedDRA coding, assessment of seriousness, and expectedness; narrative writing of ICSRs (e.g. serious adverse events, adverse events of special interest, and suspected ADRs) from the clinical trial, spontaneous and from published reports (e.g. from the literature, received from Regulatory Authorities) in Safety Database.
  • Properly documented all internal and external contacts and communications (e.g. with reporters of cases, sites, or Sponsors whether verbal or written)
  • Submitted expedited safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation, including electronic submission to the EudraVigilance database (EV Web application or Gateway), MHRA portal and FDA adverse event reporting system (post-marketing SUSAR).

Senior Shared Service Center Safety Associate

Merck Serono
02.2012 - 10.2013
  • Provided oversight of the PV operational and case management activities for safety reporting including collection, processing, reporting/submission of safety information for all Merk Serono products (investigational and commercial).
  • Tracked the local compliance on individual safety reports, clinical trial periodic reports submissions according to local regulations and providing regular compliance reports to GDS via the applicable technical tool.
  • Submitted clinical trial periodic reports & expedited individual safety reports to concerned local health authorities.
  • Supported PV vendor management oversight activities including day to day oversight, review, and evaluation of vendor performance and quality on assigned clinical trial studies.
  • Contributed to development and maintenance of safety data exchange agreements (SDEA) and PV agreements with partners, vendors and third parties.
  • Screened local literature not indexed in international databases and transmission to GDS with relevant information.
  • Collaborated with medical Affairs, Commercial team to develop training and Delivered regular PV training for all sales representatives, new hires and refresher training.
  • Provided support during regulatory authority inspections, safety partner audits, internal audits.

Drug Safety Associate

TATA CONSULTANCY SERVICES (TCS)
05.2011 - 02.2012
  • Processed spontaneous reports, solicited reports, and Litigation cases. Requisition of clarifications, follow-up and additional PV information from Client affiliates and/or subcontractors.
  • Verified the accuracy of MedDRA and WHO-DD coding of adverse events, concomitant drugs.
  • Completed the case evaluation and assessment (seriousness, listedness, company causality) for cases following the L1 path (non-serious adverse event reports) and routed cases to the Argus Distribution /Archive step under the supervision of the TA Medical Evaluator team.
  • Wrote comprehensive case descriptions (narratives) for final clinical study reports & performed structured entry of serious and non-serious adverse events from initial and follow-up reports into global PV safety database Argus.

Professional Dental Surgeon

Private Clinic
09.2007 - 04.2011
  • Treated infections of oral cavity, salivary glands, jaw, face and neck.
  • Reviewed and evaluated new products or technologies in the dental industry, staying at the forefront of advancements and integrating relevant innovations into practice.
  • Provided emergency surgeries for patients with broken teeth or facial bones, prioritizing both functionality and aesthetics during treatments.


Education

Bachelor's - Dentistry

V.Y.W.S Dental College And Hospital
Amravati, Maharashtra, INDIA
06.2006

Skills

  • Experience in direct line management and health authority inspections and internal or third-party audits
  • Core knowledge and experience of global Pharmacovigilance regulations (ICH, EMA, FDA) and affiliate environment with fair understanding of related quality assurance systems
  • Experience in developing training & quality documents (SOP / Guidelines / CAPAs)
  • Proficient in case processing processes, procedures, conventions, data interpretation and experience using excel
  • In-depth understanding of medical and drug terminology using MedDRA coding
  • Oversight of Drug safety operational and case management activities for Global safety reporting
  • Safety databases (Argus, ArisG); eTMF & PhlexEview systems, EDC systems- Rave and Datalabs
  • Able to impact across stakeholders and manage within cross-functional matrix seen as collaborative partner within organization; and identify, assess, and effectively manage business and compliance risks
  • Experience in leading cross-functional teams, establishing influencing skills, and taking initiative to understand assignments, and surrounding environment
  • Effectiveness in dealing with clients when representing company; track record of project management effectiveness and credibility with client

Timeline

Supervisor, Pharmacovigilance

ICON
06.2021 - Current

Senior Drug Safety Associate

ICON
05.2018 - 06.2021

Drug Safety Associate 2

PRA Health Sciences
10.2013 - 03.2018

Senior Shared Service Center Safety Associate

Merck Serono
02.2012 - 10.2013

Drug Safety Associate

TATA CONSULTANCY SERVICES (TCS)
05.2011 - 02.2012

Professional Dental Surgeon

Private Clinic
09.2007 - 04.2011

Bachelor's - Dentistry

V.Y.W.S Dental College And Hospital

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