10+ TCS Interview Questions and Answers

Calls handled like MI, PQC, AE involve reporting and documenting adverse events, product quality complaints, and medical inquiries.

• MI (Medical Inquiry) - Involves answering questions related to the safety and efficacy of a drug or medical device

• PQC (Product Quality Complaint) - Involves documenting and investigating complaints about the quality of a drug or medical device

• AE (Adverse Event) - Involves reporting and documenting any negative side effects or reactions experienced...read more

Precautions and improvisations for improving data management in drug safety

• Implementing standardized data entry protocols to ensure consistency and accuracy

• Regularly conducting data quality checks and audits to identify and correct errors

• Utilizing advanced data management software and tools for efficient data processing

• Ensuring data security and confidentiality measures are in place to protect sensitive information

• Providing training and ongoing support for staff involved in d...read more

Communication in drug safety involves emails, phone calls, and meetings to ensure timely and accurate information exchange.

• Emails are commonly used for formal communication and documentation of important information.

• Phone calls are used for more immediate and urgent communication, such as discussing adverse events or safety concerns.

• Meetings are held to facilitate discussions, decision-making, and collaboration among team members.

• Effective communication is essential in drug s...read more

Safety precautions during documentation process are crucial for accuracy and compliance.

• Ensure confidentiality of patient information by following HIPAA guidelines

• Double check data entry for accuracy to prevent errors

• Use secure electronic systems for storing and sharing documentation

• Regularly update and maintain documentation to reflect current information

• Train staff on proper documentation procedures to ensure consistency

Active participation during audit includes preparing for the audit, attending audit meetings, providing requested information, and addressing any findings or concerns.

• Prepare for the audit by reviewing relevant documents and processes

• Attend audit meetings and actively participate by answering questions and providing explanations

• Provide requested information promptly and accurately

• Address any findings or concerns raised during the audit by developing corrective action plans

• Fol...read more

Documentation process involves recording, organizing, and storing information related to drug safety activities.

• Documentation should be accurate, detailed, and easily accessible.

• Information should be recorded in a timely manner to ensure completeness.

• Documents should be organized in a systematic way for easy retrieval.

• Documentation may include adverse event reports, case processing forms, regulatory submissions, and communication records.

• Version control and tracking changes a...read more

The work process involves collecting, analyzing, and reporting data on drug safety to ensure the safe use of medications.

• Collecting adverse event reports from healthcare professionals and patients

• Analyzing data to identify potential safety concerns or trends

• Reporting findings to regulatory authorities and internal stakeholders

• Collaborating with cross-functional teams to ensure compliance with regulations and guidelines

I have extensive experience in performing systematic reviews.

• I have conducted systematic reviews in various fields including healthcare, education, and social sciences.

• I am familiar with the Cochrane Collaboration's methodology for systematic reviews.

• I have published several systematic reviews in peer-reviewed journals.

• I have also trained and supervised junior researchers in conducting systematic reviews.

MICC stands for Minimum Inhibitory Concentration of a drug, which is the lowest concentration of a drug that prevents the growth of a specific organism.

• MICC is a key parameter in determining the effectiveness of a drug against a particular pathogen.

• It is commonly used in microbiology to assess the susceptibility of bacteria to antibiotics.

• MICC values can vary depending on the drug, organism, and testing method used.

• Lower MICC values indicate greater potency of the drug agains...read more

MDR stands for Medical Device Regulation and SOA stands for Service Oriented Architecture.

• MDR is a regulation that applies to medical devices sold in the European Union.

• It aims to ensure the safety and effectiveness of medical devices.

• SOA is an architectural style that allows different applications to communicate with each other by exposing their services.

• It promotes loose coupling, reusability, and interoperability.

• SOA is commonly used in enterprise applications and can be i...read more

Thalidomide disaster was a pharmaceutical tragedy in the 1950s and 1960s where the drug caused severe birth defects in babies whose mothers took it during pregnancy.

• Thalidomide was marketed as a sedative and anti-nausea medication for pregnant women

• It was later discovered that thalidomide caused severe birth defects, particularly limb malformations, in babies born to mothers who took the drug

• The disaster led to increased regulations and scrutiny in the pharmaceutical industry...read more

Developed a program to automate data cleaning process for a clinical trial

• Created a program using SAS macros to automate data cleaning process for a clinical trial

• Reduced data cleaning time by 50% and improved data quality

• Handled complex data discrepancies and inconsistencies

• Collaborated with cross-functional teams to ensure timely delivery of clean data

The OECD guidelines are a set of recommendations for policies and practices to promote economic growth and social well-being.

• The OECD guidelines cover a wide range of topics including corporate governance, anti-corruption, environmental protection, and innovation.

• They are designed to help governments, businesses, and individuals make informed decisions and improve their performance.

• For example, the OECD guidelines on corporate governance provide recommendations for ensuring t...read more

The latest version of MedDRA is version 24.1.

• MedDRA stands for Medical Dictionary for Regulatory Activities.

• It is a standardized medical terminology used for the classification of adverse event information associated with the use of pharmaceuticals.

• Version 24.1 includes updates and additions to terms and codes for adverse events.

• It is important for pharmacovigilance professionals to stay updated on the latest version of MedDRA for accurate reporting and analysis.