Resume-Sathish Kumar Sure.
Resume-Sathish Kumar Sure.
Resume-Sathish Kumar Sure.
SUMMARY
Seeking a challenging role in the area of Drug safety monitoring/Pharmacovigilance, that utilizes
my skills effectively and offers scope for my professional growth along with growth of organization,
where I exploit all my creative abilities by interacting and making the organization to achieve its long-
term goals.
EDUCATION
Ward Round Participation, Medication Chart Review, Medication History Interview and
Patient Counseling.
Adverse Drug Reaction (ADR) Detection, reporting, monitoring, and documentation and
assessing suspected ADRs by using different causality assessment scales.
Provision of Drug and Poison Information.
Assessing and documentation of Drug interactions.
Expertise in Bio-medical literature search by using different databases such as Micromedex and Lexicomp
for the provision of and drug information to the healthcare professionals.
PROFESSIONAL EXPERIENCE
Responsible for data entry of Individual case safety reports into the safety database.
Process all incoming cases in order to meet timelines.
Enter and code, as applicable, case data, including but not limited to event, seriousness, reported
causality (when appropriate), medical history and laboratory data as provided by the reporter.
Review adverse event (AE) report data for completeness and verify certain fields to determine as
critical (including but not limited to reportability) as well as conformity to E2B standards.
Initiate follow-up activities to obtain additional information and clarification as appropriate.
Peer review the cases and evaluate for accuracy, consistency and completeness in the safety
database against the source document. This includes, but is not limited to, checking consistency of
narrative and other data fields, ensuring main reason for delay is entered in the routing comment as
appropriate.
Correct the data entry errors, if any, prior to routing the case in the global safety database.
Track and document all observations and recommendations on the defect tracker.
Responsible for coding of all medical history, events, drugs/procedures/indications and laboratory
tests according to the appropriate dictionary (For e.g. Med DRA, Company Product Dictionary, WHO-
DD).
In QRE Workflow
Performed quality review (QRE) for cases which are performed by case processing team.
Processing of ICSRs based on regulatory timelines and submission and narrative writing as a key
responsibility.
Implement consistent, efficient and quality processes to meet timeline and deliverables according
to requirements and standard operating procedures.
Ensure compliance of operations with governing regulatory requirements.
Create, maintain and assume accountability for a culture of high customer service.
Executive drug safety data management processes-a combination of call intake, case intake, triage
case entry, medical coding, narrative writing and case follow-up.
Assume responsibility for quality of data processed.
Performed advance query searches and provides data regarding cases with missing information.
Secondary Responsibilities
Maintain quality service and departmental standards by:
Reading, Understanding and adhering to organizational standard operating procedures (SOPs).
Attending and participating in applicable company-sponsored training.
Contribute to team effort by: Performing other duties as assigned, helping others to achieve results
and participating in applicable company-sponsored training.
CERTIFICATE COURSES
April 2018 Training on Signal Detection and Causality Assessment, offered by UMC.
September 2019 Health Research & Fundamentals by NPTEL, MHRD in collaboration with ICMR
PROFICIENCY
Compliance with guidelines: GCP and GVP.
Key skills
Application of biostatistics to clinical research
ACHIEVEMENTS
Winner in Patient Counselling Video Making 2019 at National level competition, organized by
Indian Pharmaceutical Association.
Qualified NTA UGC NET as an assistant professor.
ACADEMIC PROJECTS
INTERNSHIP EXPERIENCE
WORKSHOP ATTENDED
SOFTWARE SKILLS
PERSONAL SKILLS
Quick learner
Ability and eagerness to learn new things.
Good creativity and attitude for excellence.
Well oriented and comfortable with team work.
Easily adaptable to work environment, multitasking and punctuality.
● Contributed expertise in mega health camp conducted by TATA TRUSTS (SVICCAR) on 12th
& 13th Oct 2018, Tirupati.
● Organized free medical camps for the cause of free service to the poor.
PUBLICATIONS
1. Peraman R, Pemmadi RV, Peraman M, Sure SK. Insights on SARS-CoV-2: Emerging Outbreaks of
Viral Infections and the Need for Heightening the Antiviral Research. Indian Journal of
Pharmaceutical Education and Research. 2020; 54(3S).
2. Nirmala M, Sathish Kumar S, Priyanka J, Lavanya A, Usha B. Effectiveness of combined use of rectal
misoprostol and oxytocin for prevention of postpartum hemorrhage after cesarean section.
International Journal of Research in Pharmaceutical Sciences. 2020:11(3); 3556-62.
3. Sathish Kumar S, Deepika B, Jayasankar V, Aruna G. Bidirectional relationship between Diabetes
Mellitus and Tuberculosis. European Journal of Pharmaceutical and Medical Research. 2019:6(3);
397-403.
4. Sathish Kumar S, Surendra P, Meena K, Deepika B, Vanajakshamma V, Kapil C, Prasanna K,
Jayasankar V. “A study on impact of Anemia and prescribing patterns of Cardiovascular
Medications in Congestive Heart Failure in a Tertiary Care Hospital, SVIMS.” World Journal of
Pharmaceutical Research. 2019:8(4); 651-73.
PERSONAL DOSSIER
DECLARATION
I hereby declare that the information furnished above is true to the best of my knowledge.