SURE SATHISH KUMAR

Email id: sathishkumarsure@gmail.com

Mobile No: 7396030608

SUMMARY

Seeking a challenging role in the area of Drug safety monitoring/Pharmacovigilance, that utilizesmy
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

2013 – 2019 Doctor of Pharmacy

Krishna Teja Pharmacy College, JNTUA, Ananthapuramu 86.7%
2010 – 2012 Intermediate 92.1%
Board of Intermediate Education, Andhra Pradesh
2009 – 2010 S.S.C. 91.2%
Board of Secondary Education, Andhra Pradesh

PROFESSIONAL EXPERIENCE

I am carrying an overall experience of 1 year 8 months in Pharmacovigilance.

 Worked as Pharmacovigilance Officer-II (Quality check) in Indegene Pvt. ltd, Bengaluru from Apr-2022-
Nov-2022.

 Worked as Drug Safety Associate L-1 (Quality check) in Health Minds Consulting Pvt. Ltd from Nov-2021-
Mar-2022.

 Worked as safety Associate (Quality review) in IQVIA via Aston Carter, Bengaluru from Mar-2021-
Nov- 2021.
Case reviewing

 Perform QC review of Individual Case Safety Reports (ICSRs), both unsolicited-spontaneous, literature and
solicited report types. Literature screening for valid ICSR and non-case reports, and meet quality standards
as per the requirement.
 Undertake event processing and assist with case review for errors, completeness and quality; liaising with
teams to resolve discrepancies and encourage compliance with reporting timelines.
 Understanding the principles and concepts associated with Patient Safety case-handling process including
regulatory requirements for single case expedited reporting.
 Support the development of tools to help enhance understanding of pharmacovigilance at all levels across
the organisation.
 Coding terms as per MedDRA guidelines.
 Identify SAEs, LOE, Pregnancy case and PQC only case and inform the TLs.
 To check if the case meets the criteria per the client requirement to be Valid or non−valid workflow.
 Drafting PSUR, PADER and narratives.
 Processing of device vigilance reports of reported adverse device events/ effects or adverse reaction data
from clinical and post-marketing sources as per the applicable regulations/ guidelines.

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, triagecase
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
resultsand participating in applicable company-sponsored training.
 Assist in the generation of timely, consistent and accurate reporting of expedited reports in accordance
with applicable regulatory requirements.

As Case Processor

 Responsible for data entry of Individual case safety reports into the safety database.
 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.
 Code products specified as suspect or concomitant by the reporter.
 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 any delay is entered in the routing comment as
appropriate.
 Responsible for coding 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).

DOCTOR OF PHARMACY CLINICAL CLERKSHIPS

Pharmacy clerkship

Active participation in the following clinical pharmacy activities as a Pharm.D-Intern:

 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.

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

Key skills
 Application of biostatistics to clinical research
 Compliance with guidelines: GCP and GVP.

Technical
 Aris G (ArisGlobal) database.
 Argus safety database.
 Narrative writing.

ACHIEVEMENTS

 Received an appreciation award as a top performer of the month under category “Make it
happen” from Indegene Pvt. Ltd.

 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

 A study on prescribing patterns of cardiovascular medications in CHF – A prospective

cross-sectional study.

 Bidirectional relationship between diabetes mellitus and tuberculosis.

 INTERNSHIP EXPERIENCE

 Monitoring and reporting of detected ADRs to Indian Pharmacopeia Commission.

 Preparation of SOPs.

 Expertise in ICH-GCP guidelines.

WORKSHOP ATTENDED
1. Pharmacovigilance and reporting of adverse drug reactions held on 20 th September, 2017 Organized
by Adverse Drug Reaction Monitoring Centre, Department of Pharmacology at Sri Venkateswara
Institute of Medical Sciences, Sri Padmavathi Medical Collegefor Women, Tirupati, Andhra Pradesh.
2. International conference of 1st Indo – UK Seminar on “Pharmaceutical Education and Research:
Challenges and Opportunities” Organized by Gokula Krishna College of Pharmacy, Sullurpet.
3. Participation certificate of Module on “Pharmacy Practice Module advanced learning series-5 on
Medication Therapy Management” organized by IACP (Indian Association of Colleges of Pharmacy),
Kotturpuram, Chennai, India and Krishna Teja Pharmacy College, Tirupati.

SOFTWARE SKILLS

Office Applications : MS Word, MS PowerPoint, MS Excel.

Other skills : Scientific data retrieval from various Internet portals like
science direct, Pub med.
Typing speed : 40 – 50 words per min.

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.
EXTRA CURRICULAR ACTIVITIES
● Contributed expertise in mega health camp conducted by TATA TRUSTS (SVICCAR) on 12th
and 13 Oct 2018, Tirupati.

● Member of National Service Scheme (NSS).

● Active Blood donor.

● 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

Date of birth: 20 September 1994

Gender: Male
Marital status: Married
Permanent Address: 3-298, Main Road, Rudrakota, Kavali (M), SPSR Nellore (DT), Andhra
Pradesh - 524203.
 Languages known: English, Hindi, Telugu.

DECLARATION

I hereby declare that the information furnished above is true to the best of my knowledge.

Place: Kavali Sathish Kumar Sure