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
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Work History
Post Marketing Vigilance Specialist, 03/2012 to 06/2015
Carecloud – Englewood , OH
Carecloud – Englewood , OH
- 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. – City , STATE
Quintiles India Pvt. Ltd. – City , STATE
- 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. – City , STATE
Omega Healthcare & Management Service Pvt. Ltd. – City , STATE
- 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 - City, State
Manipal University - City, State
- Coursework in Clinical Research including all trial phases
- presenting papers on oncology & Women's health trials
Bachelor of Science: Biotechnology, 2008
Bangalore University - City, State
Bangalore University - City, State
- 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
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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