SUMMARY

• Case Processing and Adverse Event Reporting
• Product complaint analysis and management
• Firm knowledge of Argus, ArisG and Sceptre
• Aggregate Reports, especially PADERs
• Signal detection and optimization
• Proof Reading regulatory documents
• Standard Operative Procedure (SOP) generation and management
• Management of regulatory and business partner communications
• MedDRA drug dictionary
• Narrative Writing and assessment
• Causality assessment, De - challenge and Re-challenge determination
• Quality analysis of safety reports
• Writing 510 (K) and PMA sections
• Performing triage of incoming reports and case booking activity
• Literature review and literature research for various type of Adverse Events Cases
• Data entry of case information in Drug Safety Tools
• Checking the quality of processed cases
• Developing training material related to drug safety process wifin the company
• Adhering audit compliance and participating in client meetings
• Training coordination and management
• Thorough knowledge of ICH guidelines and GCP guidelines, relevant CFRs of FD&C act -1936
• Significant knowledge of CNS and CVS disorders and their current therapeutics

PROFESSIONAL EXPERIENCE

Manager

Confidential

Responsibilities:

• Responsible for all aspects of the quality system including development, management, implementation and maintenance.
• Ensure organizational compliance wif laws and regulatory requirements and maintain state of inspection readiness
• Collaborate and communicate actively wif Client'sFrance Corporate QA Unit.
• Oversee the creation, revision, review, approval, distribution, and implementation of SOPs for all activities performed on-site.
• Manage deviations and follow CAPAs until closure.
• Inform management of critical issues and assist to resolve critical issues as necessary.
• Perform training for quality activities and manage employee training files.
• Implement the external audit program.
• Manage on-site audits/inspections including responding to observations and following corrective actions and preventative actions (CAPA) until closure.
• Manage change control and perform impact assessment relating to North American system.
• Review and approve quality agreements wif partner companies
• Manage the qualification, selection and oversight of service providers performing regulated activities.
• Review the quality system on a regular basis to ensure its continued suitability, adequacy and effectiveness
• Responsible for operational oversight and final decision making in matters relating to pharmacovigilance, risk management, and medical information in North America.
• Ensure for all of client'smarketed US and Canadian products, that all safety information and reports are being handled and reported to the local health authority in a timely and accurate manner and in accordance wif current regulations.
• Coordinate and closely monitor PV, REMS/Risk Management, and Medical Information activities performed by service providers.
• Ensure post-marketing safety surveillance and commitments related to client'sproducts are implemented and tracked across all relevant functions.
• Perform reconciliation activities for PV, Medical Information, and product quality complaints
• Perform training for PV activities.
• Collaborate and communicate actively wif European Pharmacovigilance unit at HQin France in order to comply wif European requirements.
• Author and maintain Standard Operating Procedures (SOPs) for Pharmacovigilance activities performed on-site.
• Ensure record retention of all PV, medical, and regulatory documents that support safety post-market surveillance activities.
• Ensure Pharmacovigilance agreements are in place wif PV service providers and relevant business partners.

Drug Safety Associate

Confidential

Responsibilities:

• Process adverse event information, quality complaint reports received by the Drug Safety and Pharmacovigilance department and assists in the preparation of internal and external reports
• Triage incoming cases to determine seriousness for processing and reporting prioritization at the discretion of the Drug Safety and Pharmacovigilance department management·
• Review case information for appropriate distribution to internal and external business partners
• Perform accurate computer data entry of identified adverse event information and ensures the uniform and timely processing and reporting of adverse events to regulatory authorities
• Review of CIOMS, MEDWATCH form generation
• Contribute in generation and submission of PADERs and PSURs
• Assist in activities related to signal detection and risk management
• Track business partner and FDA submissions of the safety reports.
• Review adverse event information received for completeness and consistency, initiates case follow-up activities/AE query management, and independently generates narratives in accordance wif department processes
• Revise Standard Operative Procedures (SOP) and Work Instructions (WI), Update and manage reference document as needed.
• Proof read and Quality-check important regulatory and business partner communications.
• Engaging in vendor management and vendor training as needed
• Conduct vendor training sessions, training management, training coordination and material generation
• Perform quality control activities to ensure complete and accurate case information TEMPhas been entered into the drug safety database

Drug Safety Specialist (Contractor)

Confidential

Responsibilities:

• To perform duplicate search and do triage of Adverse Event Safety Reports in a database Argus and sceptre.
• Confirm the validity of safety reports and performing triage
• Assist in writing various sections of 510 (K)
• Review the sections of PMA and IDE(investigational Device Exemption
• Generating MDRs in accordance wif 21CFR803 and Device related labelling information
• Contribute in development and update of project SOPs
• Coding of company drugs using company specified Drug Dictionary and WHODD.
• Coding of Adverse events using MedDRA.
• Write concise and medically assessed narrative.
• Identify the seriousness of the cases and submit them to US FDA as per timeline.
• Develop event rankings, create dechallenge/rechallenge determinations.
• Ensure current requirements and new updates specified by client are met.
• Being available to participate in a daily teleconference call wif Client, which include training and updates from the client.
• To give required training to the new hires on the latest updates from the Client, ICH/GCP, product literature

Drug Safety Associate (Contractor)

Confidential

Responsibilities:

• Diligently evaluate cases of spontaneous reporting for Adverse Events and Product Complaints taking appropriate action in compliance wif company policy.
• Data Entry of adverse event reports into Argus, ArisG and Sceptre software
• Prepare concise case narrative and code adverse events
• Seriousness assessment of reported adverse events
• Generating follow up queries and letters
• Recording and documenting product complaint reports and monitoring product-efficacy
• Identify crisis events, trends and shifts in inquiry volume, reasons for the change and recommend action to client
• Assist healthcare professionals in documenting adverse event information wifin FDA timelines
• Processing and documentation of adverse event monitoring Forms.
• Review and assess clinical trial protocol and investigator’s brochure