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Post Marketing Vigilance Specialist Resume Example

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POST MARKETING VIGILANCE SPECIALIST
Professional Summary
Pharmacovigilance professional with extensive knowledge of medical regulations and Quality policies and a dedication to patient safety.Highly motivated and committed with a proven history of superior performance at individual, team and organizational levels. Strong ability to multitask and prioritize workloads with little or no supervision. Detail oriented.
Skills
  • Drug & Devices Safety & Quality
  • Post Marketing vigilance & Surveillance of drugs & devices.
  • Working in fast paced clinical trials safety environment.
  • Working on safety databases.
  • Medical Terminology knowledge including coding as per MedDRA, WHO-DD, ICD-9.
  • Strong organizational skills
  • Data Entry data filing & archiving
  • Strong Analytical skills including trend & statistical analysis
  • Knowledge of global Regulatory Parameters of drugs & devices
  • Computer skills – MS Word, Excel, PowerPoint, Track wise, Agile.
Work History
Post Marketing Vigilance Specialist, 03/2012 to 06/2015
Stryker Global Technology Center – Gurgaon, India
  • Independently worked for Post Marketing Vigilance of all Stryker Medical Devices marketed in India & Sri-Lanka.
  • Experienced in ISO13485 standards for Medical Devices, NC/CAPA, Audits, Change control & document control.
  • Receive & Report all Adverse Events & Product Experience Reports (PERs) from India & Sri-Lanka to the various Stryker manufacturing divisions.
  • Compile MDR & MDV reports of all marketed products for the regulatory agencies in India (DCGI).
  • Generate & compile Post marketing surveillance data for all marketed products for product registration & re-registration with DCGI in India.
  • Compile, report vigilance data & perform risk analysis of marketed products for the R&D team, for development of new Medical Devices.
  • Reporting all Product Holds & Recalls to the various Stryker manufacturing divisions & all competent Regulatory authorities.
  • Generate Safety Alerts for all marketed products and also inform about the Quality of products to the Service team & all manufacturing divisions.
  • Train all the staff for product safety, as per needs.



Designation - Associate Pharmacovigilance Specialist, 06/2009 to 08/2011
Quintiles India Pvt. Ltd. – Bangalore, India
  • Process clinical trial safety & post market drugs data by triaging initial and updated safety data, reviewing for inconsistencies, contacting sites with queries as needed, ensuring data translation, data entry in safety database; narrative writing; coding verbatim as per MedDRA & WHO-DDE dictionaries.
  • Identifying SAEs and AEs from literature sources; identifying brand of suspect product following receipt of report; identifying reporting sources; & assessing reportability and expectedness of events.
  • Advising team members on timelines, procedures and format to adopt for reporting to regulatory authorities; advising team members on changes in SAE regulatory reporting requirements in different countries.
  • Participate in the review of existing core operating procedures (COPs).
  • Interact with Physician and/or Project Medical Officer as appropriate.
  • Draft project instructions/guidelines for project and amend when appropriate.
  • Attend/present at investigator/CRA meetings.
  • QC of safety data entered by others.



Medical Coder, 10/2008 to 06/2009
Omega Healthcare & Management Service Pvt. Ltd. – Bangalore, India
  • Read medical ER charts from the U.S.
  • Code them by understanding client specifications & following specific coding guidelines such as HIPAA, AMA etc & as per ICD-9, CM-CPT.
  • Meet the productivity targets of clients within the stipulated time.
  • Ensure that the deliverable to the clients meets the highest standards of quality.
  • Liaison with specific clients when necessary.
  • Having good knowledge of both procedure & diagnosis coding by following dictionaries such as the ICD - 9 - CM, CPT etc.
  • Aid in quality analysis of the charts coded by coders in the team.
  • Prepare all documents related to the ISO process; meeting minutes, Internal logs etc. using Microsoft Office tools.


Education
Post Graduate Diploma: Clinical Research & Regulatory Affairs, 2009
Manipal University - Bangalore, India
  • Coursework in Clinical Research including all trial phases
  • presenting papers on oncology & Women's health trials


Bachelor of Science: Biotechnology, 2008
Bangalore University - Bangalore, India
  • Top of the class in all semesters
  • Recipient of best student award every year
Languages
English *Hindi
Accomplishments
    Built the complaint management system in Stryker India by training individuals, assessing gaps in the quality procedures & implementing positive changes.Lowered Turnaround time on processing complaints & recalls.
Additional Information
I hereby declare that the details furnished above are true to the best of my knowledge and belief. Dated: 4th Jan 2016 Place: Singapore Roomi Banerjee Dua
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Resume Overview

Companies Worked For:

  • Stryker Global Technology Center
  • Quintiles India Pvt. Ltd.
  • Omega Healthcare & Management Service Pvt. Ltd.

School Attended

  • Manipal University
  • Bangalore University

Job Titles Held:

  • Post Marketing Vigilance Specialist
  • Designation - Associate Pharmacovigilance Specialist
  • Medical Coder

Degrees

  • Post Graduate Diploma : Clinical Research & Regulatory Affairs , 2009
    Bachelor of Science : Biotechnology , 2008

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