Sushma Reddy

(484) 447-6729
[email protected]

Summary:

• Healthcare professional (Pharmacist) with six years of working experience in Drug Safety
and Pharmacy fields
• Expertised in collection, processing, review, and reporting of adverse events data in
compliance with applicable FDA, EMA and global regulations, and Company SOPs
• Receipt and process of AE/SAE reports (clinical study, spontaneous, literature, and
litigation), generate narratives, quality review and follow-up with clinical sites
• Expertise in data entry including coding standards of incoming serious and non-serious
adverse events using MedDRA terminology prescribed by global regulatory authorities
• Skilled in labeling of the adverse events by determining the expectedness of the reported AEs
using medication guides, Core Data Sheets, IB and USPI for both clinical and post marketed
products
• Expertise in writing comprehensive and concise safety narratives for clinical trial cases
• Performing Quality Review of Individual Safety Case Reports (ICSRs) (including Literature
articles) with respect to seriousness, causality, and listed ness of Investigational and Post-
Marketed products
• Well versed with process of SAE reconciliation against clinical data base
• Thorough understanding of coding (WHO-DD) principles and Risk Management Systems
• Assisted in preparation and review of aggregate reports PSURs, PADERs, PBRERs and
ASRs
• Good understanding of clinical trial methodology, GMP, GCP, and medical terminology
• Participation in local and global project teams, including on-time delivery of assigned tasks
• Proficiency with standard office skills, standard desktop computing programs, basic
computer service principles, and relational databases (ARGUS Safety, ARISg, Rave Safety)
• Proven ability to work in international environments and with cross-functional teams, with
good interpersonal skills, assertiveness, and team spirit
• Demonstrated leadership, people management abilities in complex global environments, and
high level competency while maintaining a strong ethics structure
• Good oral and written communication skills
Professional Experience:

Pharmacovigilance Project Manager Mar2018- Present

Shire pharmaceuticals, Cambridge, MA

Therapeutic Areas: Oncology, Urology and Hematology

• Validated the expeditedness of the adverse events by prioritization

• Reviewed the extracted information from the source documents by the associates for
completeness
• Triaged the adverse events using seriousness criteria for clinical study and spontaneous AE
reports
• Promptly and accurately interpreted and entered serious and non-serious adverse events
• Accurate coding of incoming serious and non-serious adverse events using MedDRA
terminology and WHO-Drug Dictionary
• Assessed expectedness/listedness for all the AEs with respect to suspect drugs against
medication guides, Core Data Sheets (CDS), Investigative Brochures (IB), and US Package
Inserts (USPIs)
• Written narratives as per ICH Guidelines and Company work instructions
• Reviewed, evaluated, and summarized the information in a written document and initiated
investigations if required
• Provided Company Causality assessment as per the standard templates and guidelines
• Requested all pertinent follow up information from reporters for the completion of case
reports within specific timelines as prescribed by global regulations and SOPs
• Performed weekly Scientific literature review on the company products
• Knowledgeable in periodic SAE reconciliation between drug safety and clinical trial database
• Participated in signal analysis & assessment activities in EMPIRICA Signal & Topics and
review of aggregate reports like PSURs, PADERs and Annual Safety Reports
• Maintain continuous knowledge expertise in local and global requirements for safety
reporting

Quintiles IMS - Durham, NC Mar 2015-Nov 2017

Pharmacovigilance Scientist

Therapeutic Areas: Neurology, Gastrointestinal disorders, Oncology

• Assist with case receipt, validity assessment, tracking, follow-up and regulatory reporting of
AE reports received from clinical trials and post-marketing sources.
• Conduct complete clinical review of domestic/foreign AE reports for all investigational and
marketed products.
• Assess AE reports/source documents for completeness, accuracy, legibility, and consistency
of information.
• Perform initial triage of AE reports including assessment of seriousness, causality,
expectedness and AE resolution.
• Case processing of 7-day/15-day SAE reports, non-serious adverse events, pregnancy
reports, and product quality complaint reports into the GSD (ARGUS: Clinical Trial/ ARISg:
Post-Marketing).
• Coding of medical terminologies and medications using MedDRA and WHO drug
dictionary.
• Write comprehensive narratives for clinical trial and post-marketing SAE/AE reports.
• Assess listedness of AEs using appropriate reference safety documents including IB and PI.
• Perform active follow-up with HCPs, patients, and consumers using phone calls, fax, emails,
and follow-up letters to obtain all medically relevant missing information from AE report.
• Interact with CRAs and study site personnel for clarification of information reported in case
report forms.
• Assist in management of process deviations and corrective and preventive action (CAPA)
process.
• Perform follow-up on pending CAPAs and maintain tracking mechanism to ensure timely
resolution. Maintain compliance records to ensure continuous availability for inspection.
• Generate CIOMS and MedWatch Form as applicable and complete on time submission of
expedited reports to health authorities globally.

Vigilare Biopharma Pvt. Ltd, Hyderabad, India Sep 2013-Jun 2014

Pharmacovigilance Associate

• Responsible for monitoring, tracking, and coordinating with the appropriate management
staff to ensure compliance with contract deliverables, critical indicators (CI), and physician
expectations
• Created initial case reports by directly entering information into ARGUS Safety database
• Triaged incoming cases using seriousness criteria for prioritization of daily workflow
• Performed accurate coding of incoming adverse events using MedDRA and suspected
products and concomitant medications using WHO-Drug Dictionary and Company Drug
Dictionary (CDD)
• Created clear, concise and comprehensive case narratives procured from relevant, related
information from various source documents
• Performed e2b validation and medical validation check before routing the cases to next
workflow
• Determined follow-up requirements and performed active follow-ups with reporters and
HCPs
• Performed case processing of Special Situations and Medication Errors
• Created, entered and reviewed the active moiety reports and summarized for aggregate
reporting
• Prepared and submitted product report files as outlined in Corporate Standard Operating
Procedures
• Communicated with complainant personnel as to status of Product Quality Complaint (PQC)
investigation, course of action, and the need for additional medical and/or supplementary
information relevant to the report
• Assisted the medical directors in the preparation of similar case analysis (SCA) comments
for suspected unexpected serious adverse event reports (SUSARs)
• Communicated with cross functional colleagues at global and local level in clarifying
requests and resolving the issues
• Cooperated the team members in continuous improvement of case processing to achieve
higher proficiency, accuracy and overall compliance

Jeevan Scientific Technology Ltd, Hyderabad, India Apr 2012-Sep 2013

Clinical Safety Coordinator

• Retrieval of cases from incoming faxes, files and/or electronic case receipt system, as
applicable
• Creation of transmittal form and/or electronic documentation of key information, as
applicable
• Liaison with Case Processing staff, to clarify information • Clarification of unclear or
illegible information with LSO, Call Centre, etc
• Conducting duplicate searches to determine if case is initial or follow-up
• Creation of case file (paper or electronic)
• Registry of case to complete basic data entry registry fields
• Assignment of MFR/AER number and send case numbers to LSOs/Call Centre, etc.,
•

MSN Industries Pvt Ltd, Hyderabad, TL, India Aug 2011-Mar 2012
Bioanalytical Research Assistant

• Organized, conducted and evaluated analytical results and testing

• Maintained study documentation and laboratory records
• Independently sets-up, maintained, operated and performed routine and non-routine
maintenance on general equipment, including problem identification and resolution
• Performed quality control review of data
• Informed Study Director, Principal Investigator and/or management of any problems and/or
 deviations that may affect integrity of the data; participated in corrective action of problems
• With supervisory assistance, assured technical staff compliance to SOPs and other HA
guidelines
• Performed complex analyses using unfamiliar or new methods, asking for scientific guidance
• Provided input and participated in project meetings, plans, monitors and guides project work
• Trained, mentored, and assisted less experienced staff
• Participated in new equipment and instrument assessment and qualification, as appropriate
• Participated in client visits as needed, assisted in communicating technical information
• Participated in process improvement initiatives
• Assisted in evaluation of data for incorporation into written reports
• Effectively planned and utilized personnel and resources for timely completion of assigned
projects
• Assisted in writing reports, protocols, SOPs and methods

Computer Skills:

• Operating Systems: Windows XP, Windows 8,10, Macintosh

• Safety Databases: ARGUS 5.2, ARGUS 7.0.2, EMPIRICA. ArisG,
• Other: MS Office (Word, Excel, PowerPoint, Outlook, SharePoint), BasicSQL

Education:

• Masters in Pharmaceutical Analysis & QA 2011 – 2013

Jawaharlal Nehru Technological University (JNTU), Hyderabad, TL, India
• Bachelor of Pharmaceutical Sciences 2007 – 2011
Jawaharlal Nehru Technological University (JNTU), Hyderabad, TL, India

Memberships:

• Member of Indian Pharmaceutical Congress

• Member of Indian Pharmaceutical Graduates association
• Member of American Chemical Society
• Member of American Association for Clinical Chemistry