SEARCH

Clinical Medical Safety Specialist Resume Example

Resume Score: 90%

Love this resume?Build Your Own Now
CLINICAL MEDICAL SAFETY SPECIALIST
  • https://www.linkedin.com/in/gayatri-vaidya-m-93174839/
Professional Summary
A dedicated Clinical Affairs professional with dual Master degree in Pharmacology (pre-clinical and clinical) and in Regulatory Affairs (Drugs, Medical Devices and Biologics). 05 years of work experience in Pharmacovigilance, Clinical Development, Medical Writing, Vendor Management (VMT) and regulatory affairs with good project management skills. A Mentor, a trainer with leadership skills, working with cross function teams, a SME and regulatory teams. Independently authored, patient narratives of Clinical Study Reports (CSR), reviewing study protocols. Experience in reviewing clinical documents, clinical trials phases, generating queries and SAE management. Sound knowledge of clinical trials, drug development, PV regulations, GVP, FDA, EMA, ICH and GCP guidelines. Secured Best Paper Presentation Award at ICMR sponsored conference on Polyherbal formulation in India. Received recognition awards like OPEL and WAH awards for top performer of month in Pharmacovigilance dept. Few paper publications, pre-clinical, clinical research oriented international workshops and conferences.

A dedicated Clinical Affairs professional with dual Master degree in Pharmacology (pre-clinical and clinical) and in Regulatory Affairs (Drugs, Medical Devices and Biologics). 

05 years of work experience in Pharmacovigilance, Clinical Development, Medical Writing, Vendor Management (VMT) and regulatory affairs with good project management skills. 

A Mentor, a trainer with leadership skills, working with cross function teams, a SME and regulatory teams. 

Independently authored, patient narratives of Clinical Study Reports (CSR), reviewing study protocols. 

Experience in reviewing clinical documents, ICF, CRF, FDA forms clinical trials phases, generating queries and SAE management. 

Sound knowledge of clinical trials, drug development, PV regulations, GVP, FDA, EMA, ICH and GCP guidelines.

Skills
Clinical Research, Clinical Study Reports (CSR), Investigator Brochure (IB), Clinical Trials Phases, Clinical Study Protocol and study design, HIPAA compliance and PHI on the CEC projects, Qualified Investigator Undertaking (QIU) Form, Site delegation logs (DORs), informed consent forms (ICF), Investigator Brochures (IB), Drug development plan, GCP and GDP compliance, Electronic Data Capture (EDC), IRB requirements, Clinical documentation. Proficient in operating MS- Word, Excel, PowerPoint, Outlook, SharePoint, Adobe Acrobat.

Clinical Research

Serious Adverse Events (SAE) reporting

Medical Writing

Pharmacovigilance

Clinical Study Reports (CSR)

Investigator Brochure (IB)

HIPAA compliance  

Informed consent forms (ICF) 

Case Report Forms (CRF)

Investigator Brochures (IB)

ICH GCP and GDP, FDA guidelines

Electronic Data Capture (EDC) 

IRB requirements

Clinical documentation 

  • Data management
  • Team leadership
  • Project management
  • Process implementation
  • Extremely organized
Work History
Clinical Medical Safety Specialist01/2017 to Current
AbbVie Inc
  • Working with the Vendor Management Team (VMT) with the Quality Check (QC) and review of cases from the Vendors and providing approvals and handling their queries in a timely manner.
  • Monitoring ICSR submissions to ensure the quality and compliance with Safety Data Exchange Agreements (SDEAs).
  • Working effectively with external departments and License Partners on relevant PV deliverables.
  • Exercised independent judgment in managing case processing PV deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.
  • Efficiently managing the cross functional teams and vendors in support of overall product development.
  • Served as a point of contact with vendor for managing routine activities and addressing related issues.
  • Point of contact with internal senior management for updates and timely escalation of issues requiring management attention.
  • Clinical case processing, Post-marketing surveillance cases, ICSR activities of Oncology and Immunology Team.
  • Monitor compliance with regulations, PV agreements and internal SOPs.
Regulatory Document Specialist07/2016 to 12/2016
Brigham and Women's Hospital – Boston, MA
  • Proficiently carried a role of event coordinator, quality auditor on the CEC project & planning regulatory submissions.
  • Developed procedures to efficiently collect regulatory documents from clinical sites.
  • Research and apply HIPAA compliance principles to the site dossiers and redact PHI on the CEC projects.
  • Reviewed FDA forms 1572, Qualified Investigator Undertaking (QIU) Form, site delegation logs (DORs), informed consent forms (ICF), Investigator Brochures (IB), Clinical Protocols to ensure GCP and GDP compliance.
  • Ensure consistency and accuracy of information on Electronic Data Capture (EDC).
  • Experienced in literature search, eCTD modules, QSR, IND, NDA, ANDA, IRB requirements, BLA submissions.
  • Maintained internal databases and tracking systems with project specific information.
  • Prepared study files for audit and inspections by sponsor or agencies by conducting preparatory regulatory document quality checks.
Regulatory Medical Writer11/2014 to 08/2015
Tata Consultancy Services
  • Editing and drafting of the patient narratives and including the compilation to the CSR (Clinical Study Reports) appendices.
  • Safety review of clinical study documents, including protocols, clinical study reports.
  • Assisted in the development of clinical protocols, study reports for scientific accuracy.
  • Assisted in the development and maintenance of SOPs and writing tools, templates and regulatoryguidelines.
  • Coordinated, managed the review cycles, incorporating team comments, discussion on document revision, finalization.
  • QC of safety narratives against source documents, templates and table listings.
  • Collaborated with appropriate teams to ensure all development for the assigned projects to be consistent.
  • Performed activities of writing, development of timelines, on time deliverables, participation on project team.
  • Assisted with audit preparation, document retrieval and tracking, and aid with audit finding responses.
  • Performed Data Capture and Quality Review, quality check (QC) review of the document against source documents for all products and serves as a backup for additional projects.
  • Timely suggestions to the client for the ease and smooth running of the project.
Pharmacovigilance Scientist07/2012 to 11/2014
Cognizant Technology Solutions
  • Processed Clinical Trial cases, Post Marketing Surveillance cases, Solicited Serious and literature cases.
  • Clinical safety case management and aggregate reporting responsibilities of line listings to ensure high quality.
  • Supported in safety and efficacy by analyzing, reviewing, interpreting, and providing inputs.
  • Tracked SAE cases workload within assigned area with high quality, efficiency and within the agreed timelines.
  • Managed and executed of scientific meetings, minute of meetings (MOM), summary reports, presentations of data.
  • Global and local regulatory reporting requirements for post marketing adverse event and clinical trial SAE data.
  • ICSRs activities, including expectedness assessments, causality assessments, narrative, case finalization.
  • Supported the update of Safety Management Plans, Risk Management Plans, Reconciliation plans, & ECRs.
  • Supported in the RCA/CAPA, late case investigation, approvals, case related queries, audits inspections & as a SME.
  • Supported in the signal assessment, internal Ad Hoc safety queries/reports, analyzing/summarizing safety data from various sources, with data-lock reconciliations and management of signal detection activities and risk management.
  • Ensure compliance with Safety Data Exchange Agreements (SDEAs) and regulatory reporting requirements.
Interests
Worked on ARGUS (7.1), ARGUS Affiliate, SINA, AEGIS, ARISg (9.1), clinical database (RAVE); MERGE, SharePoint. Worked with the ICD 10-CM, Medical dictionaries (MedDRA and WHO drug dictionary). •Flexible to relocate anywhere in the USA. Appearing for the CCRP exam in April 2018.
Education
Master of Science: Regulatory Affairs2017Northeastern University-

Regulatory Affairs

Master of Pharmacy: PharmacologyUniversity of Pune-

Pharmacology

Bachelor of Pharmacy (B. Pharmacy): 2010University of Pune-
Skills
Adobe Acrobat, Ad, Attention to detail, backup, Brochures, Brochure, oral communication, interpersonal skills, client, databases, product development, documentation, drafting, Editing, senior management, fast, forms, functional, GCP, IND, leadership skills, managing, Marketing, meetings, Mentoring, Excel, Exchange, MOM, Outlook, PowerPoint, MS- Word, organizational skills, organizational, presentations, problem resolution, PROJECT MANAGEMENT, project leadership, Protocols, Quality, reporting, Research, Risk Management, Safety, scientific, time-management, Vendor Management, Excellent written
Additional Information
  • Worked on ARGUS (7.1), ARGUS Affiliate, SINA, AEGIS, ARISg (9.1), clinical database (RAVE); MERGE, SharePoint. Worked with the ICD 10-CM, Medical dictionaries (MedDRA and WHO drug dictionary). •Flexible to relocate anywhere in the USA. Appearing for the CCRP exam in April 2018.
Build Your Own Now

DISCLAIMER

Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

Resume Overview

Companies Worked For:

  • AbbVie Inc
  • Brigham and Women's Hospital
  • Tata Consultancy Services
  • Cognizant Technology Solutions

School Attended

  • Northeastern University
  • University of Pune

Job Titles Held:

  • Clinical Medical Safety Specialist
  • Regulatory Document Specialist
  • Regulatory Medical Writer
  • Pharmacovigilance Scientist

Degrees

  • Master of Science : Regulatory Affairs 2017
    Master of Pharmacy : Pharmacology
    Bachelor of Pharmacy (B. Pharmacy) : 2010

Similar Resumes

View All
Principal-Medical-Safety-Specialist-resume-sample

Principal Medical Safety Specialist

Abbott Laboratories

North Chicago, Illinois