SUMMARY

*.* years of experience as Drug Safety Associate in Individual Case Safety Report Processing (ICSR) for both clinical and post-marketing drugs.

Concrete knowledge of US-FDA regulations, compliance with timelines, case report submission, adverse event reporting, review source documents and labels

Good understanding of IND safety reports, 21 CFR part 11, GCP, GLP, ICH and IRB guidelines

Excellent understanding of human physiology, pharmacodynamics, pharmacokinetics and drug interaction

Command over Drug Development process and Clinical Development Plans

Followed and adapted the best practices pertaining to GCP and protocol standards.

Experience in performing triage, evaluation, and case processing of adverse event reports received from different sources.

Experience in database management and Adverse Event/Serious Adverse Event coding and MedDRA and drug coding with WHODD

Create precise narrative extracting relevant information from the case reports.

Experience working with ARGUS database

Basic working knowledge and understanding of various adverse event reports such as SUSAR, PSURs.

Ability to prioritize, organize and multi task assignments approaching strict timelines.

Possess troubleshooting and time management skills.

Self-motivated focused achiever who can work in both team as well as individually with problem solving attitude there by producing superior outcomes

Excellent written and oral communication skills with strong interpersonal and organizational skills

Analytical, accurate, detail-oriented, and proficient in MS Office

WORK EXPERIENCE

Quintiles Technologies India Private Limited, Bangalore, India

Drug Safety Associate January 2014 to June 2015

Triaged the reports received from various sources and registered in the database after ensuring the validity of reports within set requirements.

Evaluated cases for seriousness, relatedness and expectedness according to SOP, investigator brochure or package label.

Verified the unstructured case data entered by from the source documents.

Promptly and accurately interpreted and entered all the information into database in accordance with GCP and pharmacovigilance guidelines ensuring accuracy with the source documents received.

Performed case processing including coding and writing narratives describing all adverse events reported into source document.

Created comprehensive narratives procured from relevant, related information from various source documents.

Ensured reports are compliant with ICH guidelines, FDA requirements, and internal SOPS.

Responded appropriately to inquiries from health care professionals regarding safety issues with marketed products.

Participated in periodic review and updating of SOPs and working practices to ensure they remain compliant.

Assisted for inquiry, examination, and verification of processes, data, records, regulatory compliance and PSUR.

Reviewed the SAE Reports Forms and determine and Listed discrepancies/Queries found

Maintained working knowledge of global safety regulations and guidelines including ICH and FDA requirements.

J.S.S Medical College Hospital Mysore, India

Clinical Pharmacy Intern June 2013 to January2014

Drug therapy monitoring (medication chart review, clinical review, pharmacist interventions) on inpatient service with active participation on morning team rounds.

Adverse drug reaction reporting and management.

Patient counseling on discharge medications.

Drug utilization evaluation (DUE) and review (DUR)

Provision of Drug information to healthcare professionals and patients

Trained in ICH-GCP & Schedule Y

Critical evaluation of article and preparing abstracts and preparing Literature review

Preparation of Patient information Leaflets on various diseases

Drug Formulary development process

Preparation of Poison management protocol

Zydus Medica (A division of Cadila Healthcare ltd.), Ahmedabad, India

Business Development Officer November 2010 - August 2011

Conducted medical information symposia

Maintained customer relationship and promoted pharmaceutical products in the assigned territory & improved prescription generation of assigned drug products

Conducted patient screening and awareness camps for Diabetes and Hypertension in the community and provided counseling for the same.

Conducted and attended various CMEs during work tenure.

EDUCATION

Graduate School Doctor of Pharmacy (Pharm. D)

J.S.S University,Mysore,India

Undergraduate Bachelor of Pharmacy (B. Pharm)

Rajiv Gandhi University of Health Sciences, Bangalore, India

According to General evaluation report of ECE (Educational Credential Evaluators) both the mentioned degrees have U.S. equivalence of:

1) Bachelor of Science degree with a major in Pharmaceutical Sciences 2) Doctor of Pharmacy degree

CERTIFICATION

Secured 69th rank at National Level Pharmacy Talent Search Examination-1st march 2009 Bangalore

REGISTERED PHARMACIST- G41481 (January2011- Present)

Gujarat State Pharmacy Council, India

RESEARCH PROJECTS

Assessment of Health Related Quality of Life in Patients suffering from Gastoesophageal Reflux Disease.

VISA STATUS

Permanent Resident of USA

REFERENCES: Available upon request

Contact this candidate