1. RESUME
Srividhya
Mobile: +919739258889 E-mail: shri2reach@gmail.com
Job Objective
To obtain a position that will enhance my career in drug safety or drug information in a
pharmaceutical sector.
Work Experience
Serious Case processing Quality Control Officer since Jun-2014 to present at Accenture
Pharmaceutical services, Bangalore.
Drug Safety Scientist since Sep-2011 to May-2014 at Accenture Pharmaceutical services,
Bangalore.
Senior Drug Safety Associate since 03-May-2010 to Sep-2011 at Accenture Pharmaceutical
services, Bangalore.
Worked as assistant dentist from Aug-2009 to Mar-2010 at a private dental clinic.
Professional Synopsis
 Processed almost 12000 -15000 cases
 Trained 15 individuals regarding Triage and case processing
 Good understanding of drug safety, safety database use
 Knowledge of GVP guidelines and purple guide
 MedDRA coding (17.1)
 Argus database (7.0.2)
 Empirica Trace Database (4.2)
 Line listing review
 Quality Assurance
 Ability to work independently under tight time constraints
 I was a part of the team which MHRA inspected during the month of January-2011
 Narrative writing
 Company comment writing.
 Deviation management (compliant misses reporting).
Academic Credentials

2. Bachelor of dental surgery
University: Rajiv Gandhi University of Health Sciences 2002-2008
PG diploma in clinical research and clinical data management
University: Autonomous, 2008-2009.
Serious Case processing Quality Control Officer since Jun-2014 to present
Responsible for quality check of data entered for serious and non-serious AESI cases in the core safety
database as per the SOP
Responsibilities/Authorities
 Perform In-line Quality checks on serious cases and non-serious AESI cases entered in
Global Safety Database in ordinance with the applicable Client SOP, guidelines, applicable
SLA and regulatory day.
 Perform Quality checks with reference to the agreed quality parameters and provide
feedback to the team members for findings, ensure the corrections have been performed
and document the results.
 Track and review the individual and team scores for tracking trends and identify any
immediate action to be taken.
 Analyze the errors in serious data entry, identify the root cause, formulate and implement
corrective and preventive action.
 Provide feedback to the individuals and the team on the results of the quality checks and
ensure implementation of CAPA for the errors identified.
 Act as a SME to the team, coordinate /conduct session as a part of CAPA and refresher
training as per the team’s requirements and document the trainings.
 Coordinate with quality assurance team in timely closure of SLA QC findings.
 Works closely with the team leads, tower leads and client, respective stake holders for the
timely resolution of quality issues.
 Identify, support, and implement continuous improvement activities.
 Ensure overall deal compliance to Accenture and Client process, and support internal,
client audits and Regulatory requirements.
 Plan, organize, and manage daily work to meet Quality, timelines Service levels and
deliverables.
 Perform daily responsibilities in accordance to all applicable Standard Operating
Procedures (SOPs), conventions and Client policies.
 Escalate issues or tasks outside the normal scope of work.
Drug Safety Scientist (Since Sep-2011 to May-2014) Accenture Bangalore
 Confirm that the information in the Global Safety Database is accurate and consistent with
the Source Documents.

3.  Confirm that the information has been data entered in accordance with company
Guidelines and SOPs;
 Perform medical coding for each ICSR in accordance with company Guidelines and SOPs
using MedDRA;
 Confirm the accuracy of terminology and coding and manually recode any errors or
inconsistencies as needed per Guidelines and SOPs;
 Prepare a Case narrative for each Case, which reflects the safety data. The Case narrative
should be a concise summary of the facts of the case
 Add any follow-up information to the Case narrative initially entered into the Global Safety
Database.
 Determine if any additional information is needed for clarification or if any follow-up is
necessary and take all relevant steps to obtain any missing information as stated in the
Query Rules of Operating guidelines
 Document and send queries in accordance with the Query Rules
 SOPs, for the completion of queries as needed and follow up on all outstanding queries in a
timely manner;
 Conduct a full medical assessment of all Non-Serious Cases;
 Upgrade a Non-Serious Case to a Serious Case, where applicable, following the medical
assessment and operating guidelines
 Review and modify the data entered in respect of a Case as necessary and in accordance
with SOPs.
 Approve Non-Serious Cases.
 Conduct a Local Assessment for cases that qualify for reporting to regulatory agencies in the
US and Canada based on clinical database.
 Incorporate all available responses before the completion of the Case.
 Take responsibility in accordance with company SOPs for any follow-up information contact
required.
Drug Safety Associate 03-May-2010 to Sep-2011
 Access the designated e-mail box (es) to retrieve new incoming safety information or
follow-up correspondence for existing Cases regularly and at least three (3) times per shift
and spread out over the course of each shift.
 Store all ICSRs electronically on the agreed shared drive or E-room according to workflow
SOP or Guidelines.
 Contact the Functional Lead to obtain an English translation, in the event Accenture
receives information in another language than English.
 Send in respect of any safety information, accessed by Accenture pursuant to paragraph, an
acknowledgment of receipt (including the Case number) to the Source Document sender in
accordance with Guidelines and SOPs.
 Ensure a duplicate check against the Global Safety Database is conducted in accordance
with SOPs for all ICSRs in order to determine whether there is an existing Case file.

4.  Determine if any additional information or clarification is needed and document and send
queries in accordance with the Query Rules.
 Not disclose information identifying the patient or trial subject associated with an Adverse
Event, in accordance with Guidelines and SOPs.
 Remove patient’s names and addresses, with the exception of initials, from the Case Safety.
 Reports in accordance with Guidelines and SOPs.
 Inform the applicable manufacturing Site about a Product Complaint. Where a Product
Complaint is associated with an Adverse Event or safety hazard, the results of any
investigation shall be included in a follow-up Case Safety Report.
 Ensure that all identified duplicate ICSRs and Source Documentation are electronically
stored and appropriately cross-referenced with the original Case in accordance with
applicable Guidelines and SOPs.
 Perform Queries as per the guidelines and SOPs.
 Prioritize Data Entry activities for Cases by reference to the Date of Receipt in accordance
with SOPs and Guidelines.
 Data entry of safety information, including relevant medical history and laboratory data and
therapy dates into the applicable Global Safety Database in accordance with Guidelines and
SOPs.
 Validate data consistency and make any corrections as needed.
 Submit to Case Safety Reports for scientific and medical evaluation.
 Review responses to queries when received and update the Global Safety database as
required.
 Document any amendments to the Data Entry Conventions and agree these with the client.
 Functional Lead, prior to their implementation.
 Participate in clinical study reconciliation activities, as requested by client.
 Issue reconciliation listings as requested by client to the relevant Connected Entity and to
client.
 Plan, organize, and manage daily work to meet service level timelines and deliverables.
Assets
 I am hard working and believe in keeping abreast of information related to all fields
 I have good knowledge of medicine and Pharmacovigilance.
 I have good communication skills and am self confident and proactive.
 Dedication to work
 A flexible attitude with respect to work assignments, new learning and travel.
Personal details
Father’s Name : P.Gangadhar

5. Date of Birth : 06-Apr-1985
Gender : female
Nationality : Indian
Marital status : Single
Address : #34, 4th cross, Muninanjappa garden, Subramanya swami
temple street, Kavalbyrasandra, R.T.nagar post, Bangalore-560032