Assist in the collection, cleaning, and validation of clinical trial data from various sources. Perform data entry and data review activities to ensure quality and integrity. Support database setup, testing, and maintenance activities. Track and manage queries related to data inconsistencies and work with clinical sites to resolve them. Maintain documentation in compliance with Good Clinical Practice (GCP) and standard operating procedures (SOPs). Collaborate with cross-functional teams including clinical operations, biostatistics, and medical writing. Support the preparation of data management reports and metrics. Participate in team meetings, training sessions, and project discussions.
Assist in site selection, initiation, monitoring, and close-out visits. Ensure that clinical trials are conducted in accordance with protocols, SOPs, GCP, and regulatory requirements. Verify the accuracy and completeness of case report forms (CRFs) and source documents. Maintain essential documents in the Trial Master File (TMF). Assist in resolving data queries and discrepancies with the site staff. Support investigators and site staff in trial-related activities. Participate in project team meetings and training sessions. Prepare visit reports and follow-up letters. Maintain regular communication with study sites to ensure compliance and timely data entry.
Receive, triage, and process individual case safety reports (ICSRs). Enter event data into PV databases accurately and in compliance with timelines. Code medical terms using MedDRA / WHO-DD. Assess seriousness, causality, and expectedness of cases. Conduct literature surveillance to identify potential safety signals. Assist in preparing case narratives, reports, and documentation. Support creation of aggregate safety reports (e.g., PSURs, RMPs). Ensure adherence to SOPs and regulatory standards. Bachelors or Masters in Pharmacy, Life Sciences, Biotechnology, or related field. Excellent attention to detail and analytical capabilities. Basic understanding of medical terminology and drug safety processes.
Assist in reviewing medical records and documentation for accuracy and completeness. Learn to assign appropriate ICD-10, CPT, and HCPCS codes under supervision. Support the coding team in maintaining compliance with healthcare regulations and guidelines. Participate in training programs and workshops to build coding knowledge and skills. Ensure confidentiality and security of patient health information. Collaborate with senior coders, auditors, and healthcare staff to clarify documentation. Maintain productivity and quality standards as per organizational requirements.
Assist in site selection, initiation, monitoring, and close-out visits under supervision. Ensure that clinical trials are conducted in accordance with ICH-GCP guidelines, SOPs, and regulatory requirements. Verify accuracy, completeness, and consistency of Case Report Forms (CRFs) and other study documentation. Support in maintaining essential clinical trial documents and trial master files. Collaborate with investigators, site staff, and project teams to ensure smooth trial operations. Assist in reporting adverse events and ensuring patient safety compliance. Participate in training programs and workshops to build technical knowledge and monitoring skills.
Assist in dispensing prescription and over-the-counter medications accurately. Provide medication counseling to patients under supervision. Maintain patient records and ensure documentation is accurate and up to date. Ensure inventory is managed effectively restock shelves, check expiry dates, and maintain proper storage. Stay informed about new drugs and pharmacy regulations. Collaborate with healthcare professionals to ensure optimal patient care. Adhere to ethical and regulatory guidelines related to pharmacy practice. Familiarity with pharmacy management systems/software. Basic understanding of medical terminology.
Review, analyze, and interpret medical records and clinical documentation. Assign appropriate ICD, CPT, and HCPCS codes based on medical documentation and coding guidelines. Ensure accuracy, completeness, and compliance with established coding rules and regulations. Assist in preparing coded data for reimbursement, research, and statistical analysis. Collaborate with senior coders and quality teams to resolve coding-related queries. Maintain confidentiality and security of patient health information. Stay updated with current coding standards and industry regulations.
Assist in planning, initiation, monitoring, and completion of clinical trials. Conduct site qualification, initiation, routine monitoring, and close-out visits. Ensure all trial activities are conducted according to protocol, SOPs, GCP, and applicable regulatory guidelines. Verify that clinical data is accurate, complete, and verifiable from source documents. Maintain essential documents and track trial progress in the Trial Master File (TMF). Support communication between sponsors, investigators, and site staff. Identify and resolve issues that arise during study conduct. Ensure subject safety and proper reporting of adverse events (AEs/SAEs). Prepare visit reports and follow-up letters as per timelines. Participate in investigator meetings and training sessions.
Perform case intake, triage, and processing of Individual Case Safety Reports (ICSRs). Review and validate adverse event reports from healthcare professionals, patients, and literature. Enter and maintain accurate data in the safety database (e.g., Argus, ArisG, or equivalent). Assess seriousness, expectedness, and causality of reported events. Code adverse events and drugs using MedDRA and WHO-DD dictionaries. Prepare and submit safety reports to regulatory authorities within compliance timelines. Support aggregate safety reporting (PBRERs, PSURs) and signal detection activities. Participate in quality checks, audits, and inspections as required. Collaborate with cross-functional teams to ensure timely exchange of safety data. Maintain awareness of current pharmacovigilance regulations and industry best practices.
Review patient medical records, physician notes, and diagnostic reports for completeness and accuracy. Assign appropriate ICD-10 , CPT , and HCPCS codes based on medical documentation. Ensure coding accuracy to optimize reimbursement and reduce claim denials. Maintain compliance with HIPAA and other healthcare privacy regulations. Collaborate with physicians, nurses, and billing teams to clarify diagnoses or procedures. Verify that coded data supports the medical necessity for insurance purposes. Keep updated with changes in coding guidelines and payer requirements. Participate in audits and implement corrective actions for coding errors. Prepare and submit coding reports and documentation as required.
Collect and document adverse event information from healthcare professionals, patients, and literature. Enter case details accurately into the safety database. Assist in the initial assessment of seriousness and expectedness of reported events. Maintain and update pharmacovigilance databases under supervision. Support in the retrieval and tracking of safety information. Assist in preparing and submitting individual case safety reports (ICSRs) to regulatory authorities within defined timelines. Ensure adherence to company standard operating procedures (SOPs) and Good Pharmacovigilance Practices (GVP). Support in preparation of safety reports such as PSURs, DSURs, and RMPs. Maintain accurate and organized case documentation
Collect, evaluate, and process adverse event (AE) and serious adverse event (SAE) reports from various sources (clinical trials, literature, healthcare professionals, patients). Perform case processing including data entry, coding (using MedDRA/WHO-DRL), and narrative writing in the safety database. Ensure compliance with regulatory timelines (e.g., 15-day or 7-day expedited reporting). Conduct quality checks on case reports to ensure accuracy and completeness. Assist in preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). Monitor literature and scientific publications for potential safety signals. Support signal detection and analysis activities. Maintain up-to-date knowledge of pharmacovigilance regulations and company SOPs. Collaborate with cross-functional teams including clinical research, regulatory affairs, and medical writing.