Addula Niharika
Drug Safety Associate Ll
Mysore,Karnataka
Summary
Drug safety Associate with 5 years of experience conducting research to study human diseases and drive healthcare improvements. Investigative professional leading 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.
Overview
5
5
years of professional experience
Work History
Drug Safety Associate
Clario
mysore, karnataka
03.2021 - Current
- Incorporated varying medical philosophies and idiosyncrasies of health care delivery to generate global reports.
- Navigated intricacies of drug safety databases to process adverse event reports.
- Maintained awareness of performance metrics to remain within established limits.
- Reviewed ancillary documentation to identify information for processing and electronic capture.
- Confirms case validity
- Correct the data entry errors if any, prior to routing the case in the global 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.
- Enter and code, as applicable, case data, including but not limited to event, seriousness, reported causality (when appropriate), medical history, and laboratory data as provided by the reporter.
- Code products specified as suspect or concomitant by the reporter.
- Provide the narrative, as required.
- Review Adverse Event (AE) report data for completeness and verify certain fields to determine as critical (including but not limited to reportability) as well as conformity to E2B standards.
- Initiate follow-up activities to obtain additional information and clarification, as appropriate.
- Forward cases for case review or invalid workflow in the global safety database.
- Peer review the cases and evaluate for accuracy, consistency and completeness in the safety database against the source document. This includes, but is not limited to, checking consistency of narrative and other data fields, ensuring main reason for any delay is entered in the routing comment as appropriate.
- Confirms event term selection and coding.
- Confirms/assesses event seriousness.
- Performs listedness assessment.
- Initiate SUSAR process via notification to Pfizer and routing of the case back to Pfizer for processing.
- Determine whether additional queries through the DSU are needed at this stage and document them in the global safety database with a brief description of the information needed.
- Identify spontaneous cases that are a result of stimulated reporting by adding the appropriate case classification.
- Track and document all observations and recommendations
Safety Specialist
Experis IT
Bangalore, karnataka
01.2019 - 03.2021
- Gathered information, prepared reports, and drafted correspondence related to cases.
- Supported audit procedures to check all procedures, processes and work standards.
- Verified monthly practice of fire drills for every work shift.
- Recognized, documented and advised on removal of hazards.
- Triaging of cases to ensure prioritization and to comply with the regulatory requirement.
- Handling adverse event reports categorized on basis of expeditiousness in adherence to defined reference guidance and regulatory reporting time frames. Handling of serious and non-serious spontaneous cases, ICSRs, Legal cases and Clinical Trails reports, Post-marketing surveillance reports, reports from licensing partners and regulatory authorities.
- Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
- Narrative writing according to the regulatory standards for ICSRs, Legal cases and Postmarketing surveillance reports with timely completion of the assigned data entry tasks for expedited reporting.
- Well acquainted with coding of adverse drug reactions, relevant medical data using MedDRA.
- Dealing with various big data medical records and legal source documents like civil complaints and plaintiff fact sheets etc.
- Ensure that medical and causality assessments of all clinical and post-marketing adverse event fillings to foreign regulatory authorities are consistent with company policies, as well as the respective foreign regulatory requirements.
- Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources.
- Performing QC activity.
- Raising appropriate queries to the marketing company for discrepancies and confirmations.
- Interpret regulatory mandates.
- Assist with internal and external drug safety audits.
- Remediate any Pharmacovigilance deficiencies found during regulatory or internal audits.
- Identify the correct actions and facilitate, support and implement them as appropriate.
GC Chemist
Hychem Laboratories
hyderabad, telangana
02.2014 - 04.2016
- Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records and work instructions.
- Modified and adapted standard methods and procedures to solve analytical problems.
- Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Repaired, calibrated and safely operated laboratory equipment to reduce costly instrument downtime.
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
- Engaged in research activities to develop innovative technologies and identify new opportunities and application methodologies.
- Contributed to team discussions and new project initiatives to advance progress and optimize profitability.
- Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.
- Assisted with collecting, identifying and packaging hazardous and non-hazardous waste products to comply with Resource Conservation and Recovery Act regulations.
- Adhered to social distancing protocols and wore mask or face shield.
Education
High School Diploma -
Skills
Oracle Argus 821
Arisg 7
MedDRA 240
WHODD
MS Office
Computer Skills
Excellent Communication
Multitasking Abilities
Teamwork and Collaboration
MS Excel
Timeline
Drug Safety Associate - Clario
03.2021 - Current
Safety Specialist - Experis IT
01.2019 - 03.2021
GC Chemist - Hychem Laboratories
02.2014 - 04.2016
Bhashyam Public School - High School Diploma,