Safety Project

Piy

973-***-**** (employer)

*****.*@*******.***(employer)

LOOKING FOR CORP TO CORP

Professional Summary

More than 4 years of experience in the field of drug safety

Experience with ARGUS and ARISgsafety system

Hands on experience on Serious Adverse Event (SAE) Reconciliation

Able to perform triage, evaluation and processing of adverse events from post marketing and clinical sources in accordance with FDA, ICH guidelines and company SOPs

Understanding of coding standards for serious and non-serious adverse events using MedDRA terminology and drug coding in accordance with WHO-DD

Coordinate with departments such as Regulatory, Global Drug Safety, Clinical Research Team, Research and Development, and Public Relations regarding information requests

Submission of product complaints and technical complaints to product monitoring and Quality Assurance team respectively

Excellent communication skills with demonstrated ability to communicate professionally with other scientists on patient safety information

A team oriented professional, works efficiently during deadline driven approach with a commitment to extract accurate information

Good leadership skills including training, influencing and motivating staff members to achieve company safety objectives

Remarkable project management skills, ability to manage multiple high priorities, identify resource needs, drive to completion, prepare reports, and evaluate results

In-depth knowledge of U. S Code of Federal Regulations, compliance with timelines, adverse event reporting, and query management systems

Remarkable knowledge of process for filing, monitoring, tracking, and responding to inquiries on adverse events and other medically related project information

Familiarity with medical information databases/electronic referencing databases

Advanced knowledge in Pharmacovigilance operations in reporting clinical and post-marketing drug adverse events, and regulatory environment in governing patient safety management activities

Extensive knowledge of IND safety reports and Periodic safety update report guidelines (PSURs) and assisted in PSURs preparation.

Professional Experience

Mallinckrodt Pharmaceuticals, Bedminster, NJ July 2016 – Till date

Drug Safety Specialist

Responsibilities:

Performed data entry from the source document into ARISg safety database

Receiving, processing and follow up of Adverse events (AEs) and Serious Adverse events (SAEs) reports

Triaged incoming cases by determining the seriousness and prioritizing case process according to the time frames stated in SOP as per the company and regulatory requirements

Create and maintenance project specific working files, case report files, project central files.

Processed individual case safety reports (ICSRs) and assisted in periodic safety update reports (PSURs)

Reviewed an accurate coding of incoming serious and non-serious adverse events (AEs), medical history, laboratory data and drugs using MedDRA terminology and WHO-Drug dictionaries.

Ensured that case details are completed and, when necessary, follow up with the reporting consumers and Health care professionals (HCP) to get additional information to clarify the case details.

Accurately interpreted and enter serious and non-serious adverse events into global database for distribution.

Interacted with company representatives, project teams, clinical sites, CROs, and other members of risk assessment teams

Maintained current knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and Pharmacovigilance reporting.

Ensured all Sponsor, and regulatory timeframes are met for the processing and reporting of safety information

Data collection and entry of adverse events (AEs)/Serious Adverse events (SAEs) received from clinical trials and/or post marketing sources in a timely fashion to ensure compliance with local and global regulatory reporting.

Create comprehensive narratives procured from relevant, related information from various source documents.

Comprehensive understanding of labeling (Company Core data sheet and labeling reviews)

Otsuka, Princeton, NJ Jan 2015 –May 2016

Drug Safety Associate

Responsibilities:

Performed case processing of ICSRs using ARGUS 7 safety database

Triage of incoming cases by determining the seriousness and prioritizing case process according to the time frames stated in SOP as per the company and regulatory requirements

Created and maintenance project specific working files, case report files, project central files.

Processed individual case safety reports (ICSRs) and assisted in periodic safety update reports (PSURs)

Reviewed accurate coding of incoming serious and non-serious adverse events (AEs), medical history, laboratory data and drugs using MedDRA terminology and WHO-Drug dictionaries.

Ensured that case details are completed and, when necessary, follow up with the reporting consumers and Health care professionals (HCP) to get additional information to clarify the case details.

Accurately interpreted and enter serious and non-serious adverse events into global database for distribution.

Interacted with company representatives, project teams, clinical sites and other members of risk assessment teams

Maintained current knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and Pharmacovigilance reporting.

Ensured all Sponsor, and regulatory timeframes are met for the processing and reporting of safety information

Data collection and entry of adverse events (AEs)/Serious Adverse events (SAEs) received from clinical trials and/or post marketing sources in a timely fashion to ensure compliance with local and global regulatory reporting.

Created comprehensive narratives procured from relevant, related information from various source documents.

Comprehensive understanding of labeling (Company Core data sheet and labeling reviews).

PPD, Morrisville, NC Feb 2014 - Nov 2014

Drug Safety Specialist

Responsibilities:

Collected, documented, and processed adverse event (AE) reports from clinical trials and post-marketing sources adhering to Standard Operating Procedures

Determine seriousness/non-seriousness of event and meet deadlines for reporting such events

Handled phone and written disease state and product inquiries from physicians, other health care professionals, consumers and company sales representatives and company medical personnel according to company protocol

Brought serious or potentially serious adverse event complaints and any drug safety related issues to the attention of management and/or Drug Safety Review Committee as necessary and appropriate

Participated in the triage process for incoming documents

Critically evaluated the validity of the scientific literature on prescription and competitor products using professional judgment

Performed daily responsibilities in compliance to all applicable Standard Operating Procedures (SOPs),regulatory requirements, conventions, and company policies.

Computer Skills& Core Competencies

Triaging of Adverse Event Reports

MedRA& WHO DD Coding

Extensive Narrative Writing

Critical Judgement & decision making

Therapeutic Areas – Oncology, Cardiology, & Ophthalmology

Operating Systems: Windows 7&10, Mac, MS Office

Safety Databases: ARISg, ARGUS

Education

Master of Sciences in Healthcare Administration

Wilmington University, Newark, DE

Bachelor of Pharmacy

Devi AhilyaViswavidyalaya, Indore, India.

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