ANNS JOSEPH
Toronto,ON
Summary
Drug safety associate with an year of experience conducting clinical research to support diagnosis and treatment of diseases. Critical thinker with background developing and improving methodologies and procedures for superior data analysis and reporting. Organized and dependable candidate successful at managing multiple priorities with a positive attitude.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Drug Safety Associate
Clario (formerly Bioclinica India Pvt. Ltd)
12.2019 - 01.2021
- Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields. Managed approximately 20 cases including literature and clinical trial cases per day from the sources with more than 95 percent of case passing.
- Responsible for data entry of Individual case safety reports into the safety database
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures
- Process all incoming cases in order to meet timelines
- Full data entry including medical coding and safety narrative
- Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (For e.g
- MedDRA, Company Product Dictionary, WHO-DD)
- Collaborated with physicians and other healthcare professionals to evaluate the effectiveness of treatments and diagnostic techniques.
- Streamlined case management processes, ensuring timely submission of quality reports to regulatory authorities.
Education
Doctor of Pharmacy -
The Erode College of Pharmacy & Research Institute
Erode, Tamil Nadu, India12.2018
Skills
- Familiar with pharmacovigilance terminology
- Ability to deliver within established timelines
- Skilled in performing Microsoft Office
- Project Management Experience
- Organizational skills
- Strong verbal and written communication skills and interpersonal skills
- Case processing and Adverse event reporting experience
- Data collection and Signal detection abilities
- Problem-solving capabilities and Critical thinking aptitude
- Analytical and deductive skills
- Technical writing proficiency
- Database management like Arisg, Micromedex, Lexicomp, and Medscape
- Ability to work independently and Decision-making skills
- Medical terminology proficiency
- Team collaboration
Certification
Introduction to Pharmacovigilance from UMC
Signal detection and Causality Assessment from UMC
Statistical reasoning and algorithms in PV from UMC
Timeline
Drug Safety Associate
Clario (formerly Bioclinica India Pvt. Ltd)
12.2019 - 01.2021
Doctor of Pharmacy -
The Erode College of Pharmacy & Research Institute
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