MURCHHANA MISRA
Associate Manager
Bengaluru,KA
Summary
CARRER OBJECTIVE
To be a part of an organization where the management structure recognizes and rewards loyalty, honesty, hard work and ambition of an employee by providing growth opportunities and necessary infrastructure that could contribute to the success of the company.
PROFESSIONAL SUMMARY
Overall Experience 9.2 years in core PV and Social media PV and Compliance
Currently working as Senior Specialist-Pharmacovigilance in IQVIA.
Experience in leading multiple projects, facing client Audits and dealing with Stakeholders.
Experience in MedDra Coding, preparing ontology checklist, Signal detection.
3 years of experience in ARISg Database.
Worked on Market research analysis.
4 years of experience in Adverse Event capturing in Audio/video files and worked in Automation of Audio to Text conversion.
1 one year of experience compliance which includes SOP/Work Instruction/CAPA writing.
Worked for 2 years 1 month as Drug Safety Associate in “Synowledge India Pvt Ltd”.
Have completed course on Clinical Research and Pharmacovigilance.
DIA certified in
Safety Audits and Inspections
Post marketing Safety Management”
Wiki verify certified.
Overview
13
13
years of professional experience
1
1
Language
Work History
Associate Manager
IQVIA
01.2016 - Current
- As a part of compliance team, I work with all the projects to ensure that it’s compliant as per the company standard
- Prepare SOP, WI, write CAPA
- Doing research and analysis of pharmacovigilance data in Social Media to capture Adverse Events-
- By applying analytical and logical reasoning with following the guidelines for AE tracking on healthcare related social media data or client internal records to capture Adverse events in diverse therapy areas/brands
- Project management -
- Manage long term client engagements/projects, following IQVIA best practices and methodologies, adhere to highest standards of quality and professionalism, efficient internal and external communication, resolve conflicts, consistently match expectation for all internal and external stakeholders
- Team Management -
- Leading projects, prepare project Matrix, onboarding resources to the project, impart training to the team, assign allocation, sending reports to client
- Contributing to Pharmacovigilance and regulatory knowledge management - Continuously monitor the PV space around various pharma or healthcare companies, update the team on upcoming challenges and competing companies and contribute to knowledge enhancement of the PV team
- Ensure coordination within team, across locations, and with IT services delivery team, and streamline all related processes that impact the deliverables
- Assist with the review and analysis of adverse event text records/ audio-video records/ Survey files or Source documents
- Design and develop client specific presentations/reports.
Senior Specialist
Synowledge PV Services
11.2013 - 12.2015
Trainee Medical Coder
Synowledge India Pvt Ltd
12.2011 - 09.2013
- Quality review of ICSR
- Performing MedDRA coding assessment
- Assessing causality for safety cases reports
- Perform expectedness and listedness assessment and ICSR report ability
- Generate follow-up questions for the cases
- Conduct quality review of ICSRs
- Distribution of ICSR for submission when required
- Respond to queries from clients as required
- Perform document management, including scanning and filing of source documents
- Contribute to maintenance and compliance on adverse events reporting
- Escalates to Project Leader for quality calls and requests for Health Care Professional consultation involving safety issues
- Facilitates safety monitoring by optimizing scientific quality documentation and data entry of safety case reports for pharma and clinical trial drugs
- Tracking and initialization of single case drug safety reports in the safety database
- Accurate data entry and coding of adverse event reports
- Standard operative procedures and regulatory requirements.
Drug safety Associate
Omega Health Care Private Ltd
10.2012 - 05.2013
Education
Master of Pharmacy - undefined
Royal College of Pharmacy and Health Sciences
2011
Bachelor of Pharmacy - undefined
RIPS, BPUT
2009
Skills
- Compliance and Audit Readiness
- Write SOP and Work Instructions
- Single ICSR processing
- Can process all clinical, spontaneous, Literature cases
- Basics of pharmacovigilance
- Attending Client calls
- Knowledge about MedDRA and ICD
- Good knowledge of MS Excel, MS Word and power point
- Ability to Handle Team
- Performed TL role
- Quality review of ICSR Areas of Exposure
- Excellent in processing all types of single ICSR reports
- Excellent in processing all Clinical, spontaneous, interventional and non-interventional studies/programme reports and Legal case processing (Arisg database)
- Knows role of Investigator, monitor, auditor, DSA, CRC and regulatory authorities
- Excellent negotiation, interpersonal and communication skills
- COMPUTER LITERACY
- Knows MS excel including conditional formatting, sorting and filtering, pivot table, charts, hyperlink, formula and functions
Accomplishments
- Omega Health Care Private Ltd
- Completed training on Medical Coding in Omega in one month
- Doing Medical coding using ICD 9-CM
- Able to meet the quality as well the quantity on daily basis
- Medopharm
- Review of BMRs (Batch Manufacturing Record) for its integrity, accuracy and completeness with respect to meeting predefined acceptance criteria and critical process parameter results
- Review of BMRs to check related investigation, deviation and change control
- Preparation and execution of process validation protocol/equipment/utility qualification protocol
- Preparing Annual Product Quality Review (APQR).
Timeline
Associate Manager
IQVIA
01.2016 - Current
Senior Specialist
Synowledge PV Services
11.2013 - 12.2015
Drug safety Associate
Omega Health Care Private Ltd
10.2012 - 05.2013
Trainee Medical Coder
Synowledge India Pvt Ltd
12.2011 - 09.2013
Master of Pharmacy - undefined
Royal College of Pharmacy and Health Sciences
Bachelor of Pharmacy - undefined
RIPS, BPUT
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