Dr. Neetu Chopra

Screening and review of literature search results (articles/abstracts/citations) for purposes of ICSR identification or Triaging literature search results for potential articles of interest with relevant safety information

Provide support for Central Safety Department (CSD) literature screening activities for both ICSR and signal detection purposes in accordance with their procedures and regulatory requirements.

Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
• Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
- Enters data into safety database.
- Codes events, medical history, concomitant medications and tests.
- Compiles complete narrative summaries.
- Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the
drug development process.

Creation of variations in the regulatory database to track labeling, quality or administrative changes, creation of references for responses to health authority regarding PSUSA or PBRER, Referrals etc. in the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures.

• Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling doc and SOPs, and Global drug safety regulations.
• work to ensure compliance with internal and regulatory timelines for the adverse event reporting.
• Assist in development of project specific safety procedures, workflows and templates.
• Attend internal, drug safety and project specific training sessions.
• Completes trainings assigned on internal and client Learning Management System (LMS) as applicable.
• Preparation for, participation in, and follow up on audits and inspections.
• Monitoring of incoming reports from various sources viz mailboxes, EudraVigilance, literature searches etc.
• Perform literature searches as per search strategy, performs data entry of valid cases into the safety database.
• Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations.
• Responsible for sending translation requests if any.
• Perform a check on overall medical cohesiveness and consistency of the document.

• Compares and analyses data provided by the affiliate with the data available on client application.
• Prepares ADR form/coversheet as required.
• Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool.
• Creates the case on the safety database.
• Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs).
• Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the event.
• Ensures MedDRA coding in accordance with "MedDRA Term selection: Points to Consider"
• Request follow-up and perform query management, as applicable.
• Prepares medically cohesive case narratives based upon the reported information.
• Routes the case to the next workflow state as applicable in the safety database.
• Performs quality checks/validation checks in reference to standardized QC checklist and document the errors accordingly
• Supports compliance activities for ICSRs including late case investigation of ICSRs to various Health Authorities and Business Partners to determine the assignable cause for lateness and collection of lateness documentation including corrective actions, where applicable.

• Developed lesson plans according to chemistry textbook outlines.
• Evaluated student comprehension of classroom topics in exams, quizzes and assignments.
• Planned and provided comprehensive chemistry coursework and instruction to students.
• Created and implemented developmentally-appropriate curriculum which addressed individual learning styles.
• Planned and provided comprehensive chemistry coursework and instruction to 100 students.
• Entered data into online student information system to report information.
• Taught students fundamental building blocks and advanced concepts.
• Used SMART Boards within classroom to promote strong learning environment.
• Assessed students' knowledge and skills through assignments and exams.
• Used individualized instruction techniques to educate students on patient observation, assessment, decision-making and health teaching.
• Held clinical simulation projects and provided each student with individual feedback.