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.
& Devices Safety & Quality
Marketing vigilance & Surveillance of drugs & devices.
Working in fast paced clinical trials safety environment.
on safety databases.
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.
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.
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
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.
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
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.