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VASAVI KONERU

PV Safety Specialist

Address Surrey, Vancouver, BC

Phone +1-778-***-**** (WhatsApp: +91-702-***-****)

E-mail adyhcd@r.postjobfree.com

Experienced PV Safety Specialist with a proven track record of around 4 years in the pharmaceutical industry. Known for successfully resolving issues, enhancing customer satisfaction, and driving operational improvements. Consistently recognized for outstanding performance and valuable contributions to projects. Highly adept at processing diverse ICSRs, aggregate reports, and signal reports. Possesses in- depth knowledge of quality assurance and control, clinical assessments, data capture, and pharmacy protocols. Seeking a challenging role to leverage expertise in pharmacovigilance and clinical research. Skills

Quality Assurance and Control

Pharmacist support

Clinical Assessments

Data Capture

Pharmacy protocols

Drug Formulation and Compounding

Work History

Aug 2019 –

May 2023

PV Safety Specialist

Navitas life sciences, Chennai, TamilNadu

• Processed over 10,000 ICSRs, including spontaneous, clinical trial, regulatory authority, legal cases, EDC cases, study cases, and literature case reports.

• Accountable for handling ICSRs, aggregate reports, and signal reports.

• Identified and handled duplicate/invalid ICSRs in ARGUS and Aris G following relevant SOPs.

• Ensured accurate data capture of various types of ICSRs.

• Conducted clinical assessments, including assessing case seriousness.

• Performed adverse event labeling using Investigator Brochure (IB), Prescribing Information

(PI), European Summary of Product Characteristics (EU-SPC), and US Package Inserts.

• Wrote safety narratives to provide comprehensive descriptions of adverse events.

• Assessed causality for adverse events.

• Maintained compliance with regulatory and local/global SOP timelines through proactive workflow management.

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• Served as a Quality Reviewer, performing quality checks on ICSRs processed by case processors.

• Acted as a trainer, providing training to selected case processors for data entry and quality reviewer roles.

• Accountable for training coordination and development of training documents.

• Drafted Aggregate reports (PADERs, CASRs, PBRER) and signal reports.

• Generated line listings in ARGUS/Clinevo safety database.

• Conducted literature and regulatory screenings.

Education

Jun 2013 -

Jun 2019

PHARM D (Doctor of Pharmacy): Pharmacy

JSS College of Pharmacy – Mysore

• Pursued PHARM D (Doctor of pharmacy) at JSS college of pharmacy, JSS University of Higher Education and Research with aggregate of 81.1%

• Pursued PG Diploma in clinical research at JSS college of pharmacy, JSS University of Higher Education and Research with 81%

Accomplishments

• Received the Best Performer award from management for process improvement efforts related to quality.

• Received the RnR award as a star performer for excellent performance.

• Promoted to the role of Quality Reviewer within 10 months of joining as a drug safety associate.

• Completed assigned work within timelines with over 98% quality and compliance, earning appreciation from management.

• Promoted to PV Safety Specialist based on the quality of work within 1.5 years of joining as a drug safety associate.

Languages

English

Telugu

Kannada

Additional Experience

• Clinical Research Coordinator in rheumatology/nephrology trials for 1 year.

• Hands-on experience in ICSR processing in ARGUS/Aris G safety database.

• Conducted Treatment Chart Review to identify drug-related problems.

• Provided drug and poison information services to healthcare professionals.

• Detected, assessed, reported, and managed adverse drug reactions observed in patients during ward rounds.

• Provided medication usage counseling for patients in wards and in the Ambulatory Patient

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Counseling Centre.

• Reported and communicated medication incidents observed in the wards to healthcare professionals.

• Handled patient referrals and communicated with the healthcare team.

• Completed ICH-GCP training for Clinical Trials.

Publications

• Published a case report on linezolid and cefuroxime-induced leucocytoclastic vasculitis in the Journal of Young Pharmacist, Vol 11, Issue 2, Apr-Jun 2019.

• Published a case report on methylene blue-induced hemolytic anemia in the International Journal of Medical Research and Health Sciences 2019, 8(5): 83-85.

Contact this candidate