CURRICULUM VITAE

Suman Thadishetti
Mobile: +91-9866611753
Email: suman07051984t@gmail.com

PROFESSIONAL EXPERIENCE:

Jeevan Scientific Technology Limited, Hyderabad, INDIA.

Sr. Executive Pharmacovigilance – QA: Jun 2018 to Sep 2021
 Plan, conduct and manage internal audits (System audit, Project audit) as per the plan in
compliance with SOPs and applicable regulatory requirements.
 Preparation/Review of SOPs/WIs and Policies in the PV department.
 Conduct Inprocess/Retrospective audit of cases received, raw data generated during the project
for compliance to SOPs and applicable regulatory bodies.
 Prepare/review audit reports for the audits conducted and release the audit report to auditee /
concerned personnel.
 Ensure the Quality and Integrity of Data/Reports generated are in compliance with SOP’s, WIs,
GCP, ICH and other regulatory guidelines.
 Verification of IQ, OQ and PQ documents and its compliance.
 Review of deviations, CAPA plans, late case analysis and TAT analysis.
 Provide support to internal and external audits for PV operations.
 Ensure generation of monthly performance reports in PV department.
 Develop, implement, collaborate and maintain quality systems supporting GCP, applicable GxP
standards and other applicable regulatory bodies.
 Oversee documentation, reporting and closure of compliance issues of internal procedures and
GxP standards.
 Provide regular feedback to Head-QA on level of compliance on quality and compliance issues.
 Handling of queries received from client/regulatory agencies.
 Reviewing of the data generated for Pharmacovigilance operations which include case
processing, aggregate reporting and medical information call center (MICC).
 Oversee any regulatory inspection commitments and ensures their timely closure.
 Perform other related duties as assigned by Line Manager.
Nomad Life sciences, Hyderabad, India.
Assistant Manager – Clinical Operations: June 2017 – May 2018
 Managing the workflow of the Clinical Trail operations unit.
 To coordinate the high quality and service drive output of the entire team and comply with GCP
standards.
 Communicating with clinical sites.
 Assisting the director with daily and ad-hoc tasks.
 Conduct on boarding training for new staff.
 Ensure the staff has the proper materials, system access and training to complete job
responsibilities.
 Participate in allocation of resources to clinical studies that are appropriate to their experience and
training.
 Ensuring that staffs are meeting defined workload and quality metrics.
 Participate in site/ Investigator feasibility, qualification and selection process.
 Execute activities within start-up, site monitoring, site management and site/study close-out,
according to internal SOPs and policies.
 Hold team meetings/ discussions on a regular basis and to evaluate the performance of each
individual.

Parexel International, Hyderabad, INDIA.

Drug Safety Specialist: November 2015 – May 2017
 Perform project specific safety database setup, develop data entry guidelines, and perform user
acceptance testing.
 Responsible for receiving and answering calls from people requiring medical services or
clarifications regarding a Medical Entity or Medical Device or Vaccines.
 Understanding the requirements of the callers and provide precise information during
Inbound/Outbound calls.
 Handling of different types of enquiries which include Product quality complaints, Medical
enquiries and reporting of adverse events as per the related SOP.
 Follow up calls if the adverse information is incomplete and getting in touch with the
reporter/enquirer to obtain all the required information.
 Providing approved responses to medical inquiries from external customers including healthcare
professionals and patients as well as assisting the pharmaceutical clients’ internal departments
with queries where required.
  Perform setup and deployment of worldwide reporting as required to regulatory authorities,
CECs, local ECs, and investigator sites (electronic and hard copy).
 Develop Expedited Reporting Procedures.
 Maintain local drug safety reporting requirements.
 Submission of periodic safety reports (i.e. DSUR, 6 MLL).
 Submission of safety reports to investigators via SIS (Safety Information System).
 Measure investigative site performance in conducting required tasks in SIS.
 Tracking and filing of submission cases as required.
 Work with Global PV Information Office for collection and organization of global PV
requirements.
 Develop project specific safety procedures, workflows and templates.
 Organization and coordination of study specific workflows with regard to processing and
reporting of Serious Adverse Events (SAEs).
 Delegate work as appropriate to Drug Safety Associates.
 Participate in client meetings / investigator meetings/ project specific training sessions.
 Create and maintain project specific working files, and case report files.
 Electronic documentation and quality control of drug safety information.
 Assessment of case reports for seriousness, causality and expectedness and the resulting reporting
requirement.
 Request follow-up and perform query management.
 Case reconciliation and coordinating activities with Data Management personnel.
 Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety
reports etc.
 Quality control of case reports, line listings, and tabulations.
 Provide drug safety and project specific training.
 Preparation for, participation in, and follow up on audits and inspections.
 Create and maintain project specific files, case report files and project central files.
 Attend internal, drug safety and project specific training sessions.

Parexel International, Hyderabad, INDIA.

Drug Safety Associate: May 2012 – November 2015
 Triage of incoming reports for completeness, legibility and validity.
 Initial data entry of case reports into safety database / tracking system.
 Assessment of case reports for seriousness, causality and expectedness.
  Requesting follow-up i.e. written telephone.

 Adverse event (AE) and drug coding.

 Writing case narratives.
 Perform literature searches.
 Create and maintain project specific working files, case report files and project central files.
 Assist with additional Drug Safety Specialist activities as required.
 Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-
scope of projects.
 Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities
such as: collection and review of endpoint packages review and follow-up laboratory alerts
review and follow-up patient eligibility for inclusion / exclusion in clinical trials review and
follow-up protocol violations review study specific Model ICFs according to ICH/GCP criteria.

L.V. Prasad Eye Institute, Hyderabad, India.

Clinical Research Coordinator: September 2009 – May 2012
 Conduct the trails as per ICH GCP guidelines.
 Scan patient’s data and short listing of patients.
 Help the investigator in screening patients.
 Assisting investigators in Informed Consent process, coordination and management of laboratory
samples, courier and follow-ups of lab reports.
 Drug accountability and dispensing at the site.
 IVRS for patient randomization in randomized studies.
 Investigational project management, dispensing, temperature monitoring and accountability.
 Ensure compliance of project specific schedule activities.
 Ensure compliance of SOPs (both internal & external as applicable).
 Preparation, attendance & follow up of Audit.
 Trial close out: Preparation attendance and follow up; forwarding the necessary information of
site closeout to all concerns.
 Manage patient travel reimbursement.
 Ensuring all relevant information required in the case record forms are present in the source
document.

Wellness Concepts Consulting at AIIMS (All India Institute of Medical Sciences), New
Delhi.
CRA/Care Giver: August 2007 - July 2009
 Conduct the trails as per ICH GCP guidelines.

 Assisting investigators in Informed Consent process, coordination and management of laboratory

samples, courier and follow-ups of lab reports.
 Investigational project management, dispensing and accountability.
 Ensure compliance of project specific schedule activities.
 Ensure compliance of SOPs (both internal & external as applicable).
 Preparation, attendance & follow up of Audit.
 Verify the accuracy and validity of data entered in database; correct any errors.
 Manage patient travel reimbursement.
 Ensure timely reports to project manager.
 Ensuring all relevant information required in the case record forms are present in the source
document.

EXPERTISE:
 Hand on experience on Veeva Vault and Oracle Argus Safety Database.
 Hands on experience on Medidata Rave.

EDUCATION QUALIFICATION:
 J.J College of Arts and Science, Bharathidasan University, M.Sc. in Biotechnology (First Class),
2007.
 New Science Degree and P.G College, Kakatiya University, B.Sc. Biotechnology (First class),
2004.
 S.R junior College, Board of Intermediate, Intermediate (Second Class) 2001.
 Loyola Public School, SSC Board, Secondary School Certificate (Second Class), 1999.

SKILLS:

 Database : Oracle Argus Safety Database, Veeva Vault and Medidata Rave.
 Dictionary : MedDRA 24.0 & WHO Drug Dictionary.