10+ Syneos Health Interview Questions and Answers

ASR stands for Adverse Event from Spontaneous Reporting while AE stands for Adverse Event.

• ASR is a type of adverse event that is reported spontaneously by patients or healthcare professionals.

• AE is any undesirable experience associated with the use of a medical product, regardless of whether it is related to the product.

• ASR is usually reported to regulatory authorities while AE can be reported to the manufacturer or regulatory authorities.

• ASR is often used in pharmacovigilanc...read more

Labelling criteria and umbrella terms are important for drug safety.

• Labelling criteria are the guidelines that must be followed when creating drug labels.

• Umbrella terms are broad categories used to group together similar adverse reactions.

• Both labelling criteria and umbrella terms are important for ensuring drug safety and proper communication of risks to patients and healthcare providers.

• Examples of umbrella terms include 'cardiac disorders' or 'gastrointestinal disorders'.

The current Meddra version is MedDRA Version 24.1.

• MedDRA is a standardized medical terminology used for the classification and coding of adverse events and medical product information.

• It is regularly updated to include new terms and improve the accuracy and efficiency of adverse event reporting.

• MedDRA Version 24.1 was released in June 2021 and is the most recent version.

• Pharmacovigilance professionals need to stay updated with the current MedDRA version to ensure accurate cod...read more

E2 and E3 files are both regulatory submission formats used in drug safety, but they differ in their content and purpose.

• E2 files are used for clinical trial data submissions, while E3 files are used for post-marketing safety reports.

• E2 files contain information on study protocols, patient demographics, adverse events, and clinical outcomes.

• E3 files contain information on individual case safety reports (ICSRs), including details of adverse events, patient demographics, and dr...read more

Nullifying a case means declaring it invalid or void.

• Nullifying a case is done when there is evidence that the reported adverse event is not related to the drug being studied.

• Cases can be nullified if there is insufficient information or if the event is determined to be unrelated to the drug's mechanism of action.

• Nullification may also occur if the reported event is a known side effect of the drug and does not require further investigation.

• Examples of nullifying a case includ...read more

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Pharmacovigilance involves monitoring and evaluating the safety of drugs

• It aims to identify and prevent adverse drug reactions

• It involves collecting and analyzing data from various sources such as clinical trials, spontaneous reports, and literature

• Pharmacovigilance plays a crucial role in ensuring patient sa...read more

To retain subjects in a clinical trial, it is important to establish good communication, provide incentives, and ensure convenience.

• Maintain regular and effective communication with subjects to address any concerns or questions they may have.

• Provide incentives such as compensation, travel reimbursements, or gift cards to motivate subjects to stay in the study.

• Ensure convenience by scheduling study visits at convenient times and locations for the subjects.

• Educate subjects abou...read more

Susar stands for Suspected Unexpected Serious Adverse Reaction. It is a term used in pharmacovigilance to describe adverse reactions that are unexpected and serious.

• Susar is an adverse reaction that is unexpected and serious

• Unexpected means that the reaction is not listed in the product information or is different from what is expected based on the known safety profile of the drug

• Serious means that the reaction results in death, hospitalization, disability, or other significa...read more

Drug dictionaries are used to standardize drug names and facilitate communication between healthcare professionals.

• Drug dictionaries can be national or international

• Examples of national drug dictionaries include the US National Drug Code (NDC) and the UK Dictionary of Medicines and Devices (dm+d)

• International drug dictionaries include the World Health Organization's International Nonproprietary Names (INN) and the Anatomical Therapeutic Chemical (ATC) classification system

• Dru...read more

Central lab data reconciliation is the process of comparing and resolving discrepancies between data collected from different labs.

• It involves comparing data from different labs to ensure accuracy and consistency.

• Discrepancies are identified and resolved through communication with the labs.

• The process ensures that the final data is reliable and can be used for analysis.

• Examples include comparing results from different blood tests or imaging studies.

I have worked on therapeutic indications such as oncology, infectious diseases, and cardiovascular disorders.

• Oncology

• Infectious diseases

• Cardiovascular disorders

I am a visual learner who benefits from seeing information in charts, graphs, and diagrams.

• I learn best through visual aids such as infographics and videos

• I prefer to take notes with color coding and highlighting important information

• I enjoy using mind maps to organize and connect ideas

Invoicing order to cash involves the process of generating invoices and receiving payments for goods or services provided.

• Ensure accurate invoicing of products or services rendered

• Follow up on outstanding payments and collections

• Maintain records of invoices and payments received

• Coordinate with sales and finance teams for seamless order to cash process

End to end CDM activities involve managing clinical trial data from start to finish.

• Designing data collection forms

• Data entry and validation

• Database lock and analysis

• Ensuring data quality and integrity

• Adhering to regulatory requirements

• Collaborating with cross-functional teams

Argus latest version is 8.1

• Argus latest version is 8.1

• It includes new features and enhancements for better patient safety monitoring

• Users are encouraged to upgrade to the latest version for improved functionality