Priyadarshini Shankaranarayanan
Summary
To pursue a highly rewarding career and obtain a valuable position in a challenging and healthy work environment where I can utilize my education, knowledge and professional work experience efficiently to reach new heights in the field of clinical research and pharmacovigilance and contribute towards organizational growth.
Presently, I am working at Accenture, Chennai as a Senior PV Quality Reviewer in PV Compliance and Quality team. I have completed my MBA from International Technological University, California, USA plus Bachelor of Dental Surgery from India, with 14 years of varied work experience in the areas of pharmacovigilance, clinical research, health administration and dentistry, both in the USA and India.
I am a seasoned, energetic, ambitious and focused individual. I undertake complex tasks and handle situations in a responsible and decisive manner. I have a great eye for detail, enthusiastic towards learning and enjoy overcoming challenges. I am a good team player and strive to achieve objectives on time and with excellence. Throughout my dynamic career, I have overseen the entire spectrum of Adverse Event Processing, aligning seamlessly with Good Pharmacovigilance Practices (GVP) and international reporting regulations. I bring my clinical insight and medical expertise to the pharmacovigilance landscape, with a view towards continuous improvement, innovation, automation, and a commitment to excellence.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Senior PV Quality Reviewer
Accenture Services Pvt Ltd
10.2022 - Current
- Perform Quality Monitoring of cases to assess quality, including accuracy and consistency of data entered in the Adverse Event Processing system database as per recommendation from the client team
- Responsible for communicating Quality Monitoring results to client team via weekly scorecards
- Plan, organize and manage daily work to meet PVC&Q service level timelines
- Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and client policies
- Collect and summarize case quality control results
- Calculate trends of quality control results for single case processing.
Medical Services Senior Analyst
Accenture Services Pvt Ltd
06.2013 - 10.2022
- Review all forms and documents pertaining to an individual case safety reports (ICSR) for errors, missing information, legibility
- Encode verbatim terms using MedDRA dictionary for patient history, product information, event information and other MedDRA dictionary-controlled fields
- Enter labeling information as per ICSR requirements based on the SOPs and Manuals
- Responsible for writing narrative summaries in ICSR on reported adverse event cases
- Attach appropriate queries and add follow-up letters as per SOPs
- Responsible for completing the validation checks and E2B checks and routing to Medical Review
- Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and client policies
- Plan, organize, and manage daily work to meet service level timelines and deliverables
- Work with the Safety Review team lead or manager to escalate issues or tasks outside the normal scope of work.
Associate Dentist (Part-Time)
Nihar Dental Clinic
06.2012 - 05.2013
- Performing diagnosis and restorative procedures (including Root Canal Treatment), prosthetic and cosmetic procedures (dentures, ceramic veneers, crowns and bridges), extractions, impactions and other oral surgeries
- Provided preventive oral care, awareness and conducting oral health screening in the surrounding communities.
Clinical Research Associate (Contract)
Horizon Technologies Inc.
10.2011 - 05.2012
- Conduct on-site clinical monitoring, site management and site administration activities, which includes document review, ensuring accurate data recording, verifying patient data, drug accountability and monitoring adherence to the protocol in accordance with ICH-GCP guidelines and Standard Operating Procedures
- Act as a site liaison to develop and maintain rapport with study site personnel and ensure ICH-GCP/ protocol compliance
- Participate in the preparation and coordination of investigator meetings or other investigator site training
- Perform in-house site support activities, responding to various site inquiries (study materials, protocol, study documents, CRFs, queries, payments, etc.) as well as appropriately tracking and documenting the same
- Assist in the development and maintenance of study documents such as CRFs, ICF and other training materials
- Establish working relationships with other team members to ensure that study-specific documentation is retrieved, filed and maintained with high quality and in a timely manner
- Identify and report serious compliance issues to senior CRA staff and clinical management, and participate in developing action plans
- Communicate progress of study and relevant information to Project Manager/ Sr
- CRA and other project team members to resolve data discrepancies, compliance, and/or regulatory issues.
Clinical Research Associate
The Veritas Healthcare Solutions LLC
09.2010 - 09.2011
- Conduct on-site clinical monitoring, site management and site administration activities, which includes document review, ensuring accurate data recording, verifying patient data, monitoring adherence to the clinical trial protocol in accordance with GCP/ICH guidelines, and Standard Operating Procedures
- Ensure timely submission of protocol / consent documents for EC/IRB approval
- Prepare, maintain and archive all files and documentation pertaining to the studies periodically for accuracy and completeness including training documents, inventory, site regulatory documentation, subject data files and correspondence during the course of the study
- Assist in the development and review of study specific documentation, including drafting protocols, CRFs, questionnaires, study start-up packets, monitoring checklists as well as training materials
- Motivate investigators in order to achieve recruitment targets
- Maintain regular contact with study sites to ensure protocol/GCP compliance
- Assist site coordinators, investigators and field clinical staff in collecting data in a timely manner that meets the protocol requirements
- Communicate progress of study and relevant information to Project Manager/ Sr
- CRA and other project team members
- Ensure the correct storage of drugs and diligent drug accountability in accordance with SOPs.
Healthcare Administrator
Access Dental and Medical Center
08.2009 - 08.2010
- Monitoring and ensuring a smooth flow of operations within the dental office by implementing recommendations on quality assurance and patient safety
- Ensuring overall quality and completeness of medical record with effective concurrent chart clinical review and query outcomes before discharge
- Educating physicians on correct documentation in physician pay for performance using International Classification of Diseases (ICD) coding guidelines with accurate medical terminology to improve accuracy in documentation of severity of illness
- Participating in study meetings, surveys and inspections conducted by authorized government agencies
- Performing final chart reviews prior to Insurance verification
- Conducting performance evaluation for the employees
- Directing and coordinating marketing and promotional activities and conducting dental and medical camps.
Dental Externship
Access Dental and Medical Center
08.2008 - 08.2009
- Assisting in various procedures including root canal treatments, implant and impactions
- Provide Oral Hygiene and post-operative instructions
- Ensuring recare is maintained along with retaining patient contacts.
Dentist
JSK Dental Clinic
05.2005 - 06.2007
- Maintaining patient records and assisting in diagnoses and treatment plan
- Performing diagnosis and restorative procedures (including Root Canal Treatment), prosthetic and cosmetic procedures (dentures, ceramic veneers, crowns and bridges), extractions, impactions and other oral surgeries
- Provided preventive oral care, awareness and conducting oral health screening in the surrounding communities.
Education
MBA -
International Technological University
San Jose, California01.2010
Bachelor of Dental Surgery (BDS) -
Meenakshi Ammal Dental College
Chennai, India01.2006
PG Diploma in Clinical Research, Clinical Data Management and Pharmacovigilance -
Clinotek India Pvt. Ltd.
01.2013
Skills
- ICH-GCP
- Pharmacovigilance
- MedDRA
- Quality Control
- EDC
- Clinical Monitoring
- ArisGlobal
- HIPAA
- ARGUS
- FDA
- Communication
- Dentistry
- Regulatory documentation
- Document Review
- Data Accuracy & Consistency
- Microsoft Office
Certification
- Healthcare Leadership
- Patient Safety
- Quality Improvement
- Clinical Research Associate- The Veritas Healthcare Solutions LLC, NY
Affiliations
- Association of Clinical Research Professional (ACRP), 1475402
- Indian Dental Association (IDA), 9223
Projects
Anti-tobacco Movement as a part of Public health awareness. Prevalence of Dental Caries among 5-13 year old children at Padma Seshadri School. Community and School Health Camps to assess oral health. Case Study on creating a Marketing Plan for Eagle One Company. Case Study involving the Impact of Fiscal Policy on the economy. Project paper on Music as a Medicine for Brain. Project report on Patient Safety and Quality Improvement.
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Tamil
Bilingual or Proficient (C2)
French
Beginner (A1)
Timeline
Senior PV Quality Reviewer
Accenture Services Pvt Ltd
10.2022 - Current
Medical Services Senior Analyst
Accenture Services Pvt Ltd
06.2013 - 10.2022
Associate Dentist (Part-Time)
Nihar Dental Clinic
06.2012 - 05.2013
Clinical Research Associate (Contract)
Horizon Technologies Inc.
10.2011 - 05.2012
Clinical Research Associate
The Veritas Healthcare Solutions LLC
09.2010 - 09.2011
Healthcare Administrator
Access Dental and Medical Center
08.2009 - 08.2010
Dental Externship
Access Dental and Medical Center
08.2008 - 08.2009
Dentist
JSK Dental Clinic
05.2005 - 06.2007
MBA -
International Technological University
Bachelor of Dental Surgery (BDS) -
Meenakshi Ammal Dental College
PG Diploma in Clinical Research, Clinical Data Management and Pharmacovigilance -
Clinotek India Pvt. Ltd.
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