Priyadharshini .R

**A, Nagappan Street

Nemillicherry, Chrompet

Chennai - 600044.

acv51x@r.postjobfree.com

91-974*******

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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