AKSHIKA MUNGALPARA

PROFESSIONAL SUMMARY

An experienced pharmacovigilance associate in AE reporting and database management. I hold a clear understanding about drug safety, regulatory guidelines and post marketing surveillance.

Processing as well as managing of SAEs in the PvEdge database as per client specific instructions.

Process ICSRs (Individual Case Safety Report) adhering to ICH guidelines. Detailed analysis of the case to identify ADR (Adverse Drug Reaction), suspected drug, medical history, concomitant medication, lab reports and any other relevant information provided.

Coding with the latest MedDRA version, causality assessment, drug labeling, filling in ANDA numbers, narrative writing and self quality check. To report ADR (adverse drug reaction) within the given time period (based on the seriousness of case and submission or expediting criteria of respective MAH). Requesting follow ups.

Reporting the team lead about issues regarding non-compliance. Timely revision of work instructions, guidance documents and SOPs. Illustrating the clients with the functioning of case processing team during the annual audits

-ICSR Case Processing

Lambda Therapeutic Research Ltd. India June 2021 - October 2022 Pharmacovigilance Associate

EXPERIENCE

PHARMACOVIGILANCE ASSOCIATE

+1-940-***-**** adzzaq@r.postjobfree.com linkedin.com/in/akshika-mungalpara-8900731a0/ CERTIFICATIONS

Registered Pharmacist of India.

Seminar on herbal drugs, India.

Recent Advances in Natural Product Chemistry for Drug Discovery, India. SKILLS

EDUCATION

Bachelor of Pharmacy 2016-2020

Atmiya University, India

Communication skills

Detail oriented

Problem-solving skills

Time management

Case management

Work Ethics

-Soft Skills

Microsoft Office

PvEdge Database

XML

-Technical Skills

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