Clinical Research Safety
Resume:
Priyadharshini .R
**A, Nagappan Street
Nemillicherry, Chrompet
Chennai - 600044.
************@*****.***
Summary
I hold an experience of 7 years in pharmacovigilance and Aggregate reporting domain.
I also involved in managerial, processing, quality review of safety narratives in ICSRs along with Safety Aggregate reports (RSI, SDEA, PBRER/PSUR, Annual safety reports). I'm involved in various roles supporting the projects. Exposed to the safety database migration activities. Good exposure to Various Medical Terminologies and Clinical research procedures. Strong affinity with business needs processes and goals.
Professional Profile
Employer Quintiles Services, Bangalore
Designation Senior Operations Specialist
Pharmacovigilance Domain
Date of Employment Jul -2016 to Till date
Employer Synowledge Services India Private Limited, Bangalore
Designation Team Leader – Pharmacovigilance domain
Aggregate Report Analyst – Regulatory Affairs
Date of Employment Feb 2011 to May 2016
Employer Accenture Services India Private Limited, Chennai
Designation Safety Reviewer
Pharmacovigilance Domain
Date of Employment May -2007 to Aug -2008
Employer Medusind Solutions India Private Limited, Chennai
Designation Editor in Medical Transcription & Workflow Coordinator
Date of Employment July -2006 to Apr -2007
Skill Sets
Operating System : Windows.
DBMS : MS Office, Oracle Clinical, SQL
Database worked : Argus 6.0, Cares, Arisg 5.3, 6.0 and 7.0
Clinical Research
Protocol, Regulatory affairs and documentation, Safety database migration, PSUR/PBRER, SmPC, SDEA, RSI, Pharmacology, Clinical trial operating, ICH-GCP, Schedule “Y”, Familiar with search engines (PubMed), CRF design, 21 CRF part 11 (electronic submissions), Causality assessment, Narrative writing, Generating Data Clarification Forms, Electronic Data Capture and ICH Guidelines.
Detailed Experience
PROJECT : PHARMACOVIGILANCE
Organization : Synowledge
Therapeutic area : Fertility, Cardiovascular, Diabetic, Consumer health care
Neurodegenerative and Oncology
Duration : Feb 2011 – May 2016
Environment : Phase III, Post marketing, Literature and legacy cases.
Roles : Team Lead
Responsibilities as a Team Lead include:
Performs pharmacovigilance activities for the assigned project
• Manage and lead processing and QC team and ensure that all tasks are performed
• Manage current incoming cases in order to meet timelines [compliance and TAT monitoring]
• Follow up with Clients regarding outstanding queries and reconciliation of discrepancies
• Ensure that team follows workflow procedures, SOPs and case processing guidelines
• Train, mentor, oversee and guide the activities of the Drug Safety and Senior Drug Safety Associates
• Completing appraisal process for the team
• Participate in short-listing associates for the team
• Maintain high level of proficiency at all workflow tasks
• Develop reports in Business objects, communication with the client on hurdles.
• Work with cross-functional divisions including Customer Support, Professional Services
• To ensure client’s compliance to PV regulations for both investigational and marketed products
• Engage with the client on weekly basis and ensure new updates are implemented as per conventions
PROJECT : SAFETY AGGREGATE REPORTING
Organization : Synowledge
Therapeutic area : Over-the-counter medications
Duration : May 2013 – Jun 2015
Roles : Regulatory documentation specialist
Responsibilities as a Regulatory Documentation Specialist include:
Comply with all applicable service level agreements for Aggregate Report analysis deliverables.
Review, write and refine the draft of Aggregate Safety Report (RSI, SDEA, PBRER and Annual Safety Reports).
Conduct analysis of single cases to determine the relevant section in aggregate reports
Create all documents in accordance to all applicable Standard Operating Procedures (SOPs), and conventions.
Plan, organize, and manage daily work to meet service level timelines and deliverables.
Work with the Aggregate Safety Reporting lead to escalate issues or tasks outside the normal scope of work.
Attend a kick-off meeting and regular teleconferences with client partners during the preparation of Aggregate Reports.
Work closely with case processing service operations to resolve issues, if any.
Provide client with a summary of the most frequent and most Serious Adverse Events, grouped per system organ class or Serious Adverse Experiences, grouped per body system, as specified per client Guidelines and SOPs
Address all review comments by both internal and external stakeholders.
Education
2003 – 2005 Bachelor of Science, Microbiology 64.0 %
Vels College of Science, Madras University, Chennai.
2000 – 2002 Higher Secondary 72.3 %
Mount Christian Higher Secondary School, Chennai, India.
1999 – 2000 Matriculation 81.2 %
Mount Christian Matriculation School, Chennai, India.
Certification
Advanced Diploma in Clinical Research, Clinical Data Management and Regulatory Affairs.
Clinotek India – Bangalore (2009)
Post Diploma in Medical Laboratory Technology (PGDMLT)
Loyola Institute – Chennai (Apr 2006)
Personal Particulars
Father’s Name: Rajamannar
Gender: Female
Date of Birth: 15th September 1985
Citizenship: Indian
Language Known: Tamil, Telugu, English and Hindi.
Mobile: +91-974*******
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