DR.Srikanth Kunduru
Cedar Rapids,IA
Summary
- Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills.
- Enthusiastic, dedicated Pharmacovigilance expert with two years of experience in Clinical and Pharmacovigilance, which includes Case processing,Case booking, Data entry, MedDRA Coding, Narrative Writing and performing literature reviews.
Overview
2
2
years of professional experience
Work History
Drug Safety Associate
Thermofisher scientific
INDIA, Telangana
08.2021 - 09.2023
- ARGUS_Case processing and Book_In for 2 years.
- Narrative writing
- Medical writing
- Literature review
- MedDRA coding
- Case reporting and medical Evaluation of ICSR
- Quality Check
- Familiar with the different steps in signal detection and management. Risk management and Benefit- Risk management.
- Familiar with WHO, CIOMS and EMA terms in signal detection.
- Performance of Triage, Data entry, Case processing, Book -In.
- Familiar with regulatory and pharmacovigilance guidelines.
- Triage incoming cases for daily workflow management Perform quality control activities to ensure complete and accurate case information.
- Coordinates the timely review of serious and non- serious adverse events, tracks all necessary data and generates reports for the project.
- Review and process serious adverse events,spontaneously reported adverse drug reactions and other medically related information.
- Ensuring regulatory compliance and adherence to Good Clinical Practice standards.
- Contributing to the timely and accurate reporting of adverse events to regulatory authorities.
Education
Pharmacy - Doctor of Pharmacy [ Pharm D ]
RajivGandhiUniversityOfHealthSciences
INDIA, BANGALORE08-2020
Skills
- Knowledge of safety databases (ARGUS & ARISg)
- Knowledge of clinical research and clinical trails
- Knowledge of pre-and post-marketing Pharmacovigilance
- Excellent knowledge and familiarity with medical terminology
- FDA and ICH and safety reporting guidelines
- Ability to work collaboratively as part of a team
- Self-motivation and the ability to drive results independently
- Aggregate reporting, Signal detection, Risk management
- Excellent oral and written communication skills
- Computer skills : Microsoft office Word, Outlook, Powerpoint and Excel
Timeline
Drug Safety Associate
Thermofisher scientific
08.2021 - 09.2023
Pharmacy - Doctor of Pharmacy [ Pharm D ]
RajivGandhiUniversityOfHealthSciences