Confidential Sr. Drug Safety Specialist ❖ Handle the responsibilities of reviewing and processing adverse events reported. ❖ Perform investigational and marketed product associated SAE and AE medical narrative composition and final review. ❖ Assess and triages adverse event reports according to seriousness, expectedness and reportability. ❖ Ensure Triage of incoming cases by determining the seriousness and prioritizing case process according to the time frames stated in SOP's as per the company and regulatory requirements. ❖ Manages US/global adverse event mailboxes and drug safety phone line. ❖ Communicate via phone/fax/email with physicians, study coordinators, consumers, care givers and other parties reporting. ❖ Perform data entry into ARGUS data base. ❖ Responsible for data entry of adverse event reports from post marketing, spontaneous and clinical trials into the Argus safety database. ❖ Performs basic searches for open data queries within the ARGUS safety database. ❖ Perform medical coding using MedDRA and WHO-drug dictionaries with relevance to SAE analysis and SAE coding. ❖ Assess adverse events and serious adverse events against company core data sheet, investigators brochure and package insert. ❖ Discuss with the medical review team regarding the serious cases with events, outcome, action taken and medications. ❖ Perform self QC of reports. ❖ Acts as the primary liaison between patient support programs and the drug safety case managers ❖ Generates follow-up letter requests to reporters. ❖ Performs quality review of generated adverse event case reports in ARGUS by junior drug safety coordinator team members. ❖ Ensure adherence to company policies and meet departmental and regulatory requirements. Interact with investigational sites and internal clinical teams to provide safety expertise. ❖ Manages case distribution for review by drug safety manager and physician. ❖ Perform safety review of clinical data (CRFs) and patient laboratory documents. ❖ Discuss with the CRA's regarding the adverse event capturing from the clinical trial data. ❖ Review study specific model ICF's according to ICH/GCP criteria. ❖ Responsible for mentoring junior drug safety Coordinator team members. ❖ Performed all Corrective and Preventative Actions activities within the required timeframes to ensure compliance ❖ Maintain well-documented files for process reviews and issue investigations ❖ Coordinated the timely collection of reasons for late reporting and corrective actions to prevent future late reporting from clinical, regulatory and marketing for inclusion in safety reports to regulatory authorities. ❖ Assists in the preparation of PSUR's, DSUR's, annual reports to the FDA. ❖ Prepares and coordinates submissions of expedited drug safety reports to the FDA and international regulatory authorities. ❖ Assist in reviewing safety sections of clinical trial protocol, investigator brochures, informed consents, clinical study reports, annual product reviews, annual safety reports and IND annual safety reports. Confidential Drug Safety Associate ❖ Responsible for timely collection of data and accurate entry of data into the company's safety database, Argus, while ensuring timeliness and accuracy of expedited reports. ❖ Received and processed Clinical Trail and Post marketing Adverse Event reports. ❖ Ensure that case details are complete and when necessary, follow up with the reporting consumers and health care professionals to get additional information to clarify the case details. ❖ Post marketing Adverse Event reporting, SAE evaluation reports, coding events, and writing narratives, Processed Adverse Events, Adverse Drug Reactions and Alert Reports. ❖ Review and code adverse events, medical history, laboratory data and drugs using appropriate event term selection in MedDRA and WHO-Drug dictionaries. ❖ Interacted with the Medical Department regarding clarification of medical issues related to SAE reports, including identification and MedDRA coding of AE terms. ❖ Experience in medical review of SAEs, including assessment of possible relatedness and expectedness. ❖ Create comprehensive narratives procured from relevant, related information from various source documents using strong clinical interpretation skills and understanding of medical terminology. ❖ Provide Analysis of similar events information for SUSAR cases. ❖ Reviewed and discussed Off-label use of medicinal product with the label committee team. ❖ Processed Product Complaints, when AE appeared to be associated with a particular lot or batch of drug supply. ❖ Determine seriousness and labeling of events as well as local and global reportability to process adverse event reports according to established guidelines. ❖ Queried licensing partners and the sites for any follow up events of SUSARs and QC of narratives completed by Drug Safety Associates. ❖ Interact with consumers, health care providers, company representatives, project teams, clinical sites, and CROs, to ensure accurate, consistent and compliant processing of safety data. ❖ Oversee distribution of adverse event reports to ensure compliance with regulatory reporting guidelines. ❖ Participate in the preparation of annual reports, core data sheet, investigator brochures and package inserts. ❖ Knowledgeable in safety policies and procedures as well FDA regulations, ICH guidelines and GCP. ❖ Generating and submitting CIOMS-II line-listing reports ❖ Review of SUSARs and non SUSARs in clinical trial study and post marketing studies. ❖ Assisting in preparing safety related sections (Clinical summary/narrative) of IND, NDA, PSUR. ❖ Delivering support to regional Marketing and Product Teams and Training other employees in their role in identification/recognition and reporting of adverse events and safety. ❖ Ensured US drug safety reporting regulations, ICH guidelines, and internal procedures are applied to AE cases. ❖ Responded effectively and in a timely manner, to a high volume of cases and multiple follow-up activities. ❖ Discussed cases directly with physicians and negotiating alternatives to the plan of treatment. Confidential Clinical Research Assistant ❖ Responsible for activities involved in the conduct of clinical trial. ❖ Responsible for monitoring clinical trials ensuring proper protocol adherence, reviewing source documentation, verifying case report forms, informed consent. ❖ Coordinating site initiation visits, submission of study protocols and other documents to ethics committee. ❖ Comply with company policies, standard operation procedure (SOPs) and regulatory guidelines. ❖ Identify issues and problems for resolution by lead Clinical Research Associate (CRA). Monitoring visits include evaluation, initiation, interim, and close out visits. ❖ Responsible for reviewing critical documents, ensuring proper investigational study product accountability, and to Good Clinical Practices (GCP), investigator integrity, and compliance with all study procedures. ❖ Enrollment: Coordinate the screening and enrollment of the patients according to the protocol, GCP, and Regulatory guidelines. Ensuring that the source notes are according to the ICH-GCP requirements. ❖ Ensure protocol compliance of the studies through reviewing patient eligibility, patient Inform Consent Form (ICF), investigational product dispensing, dosage administration and other protocol guidelines. ❖ Ensure prompt reporting of Adverse Events to the CRA and IEC by the study team. Ensure trials are ICH/GCP Compliant. ❖ Maintaining and ensuring quality of case report forms in electronic (eCRF) and paper formats (CRF) maintaining source documents ❖ Assuring adequate reporting of adverse events and ensuring that the collection of data from medical records, subject interviews, questionnaires, diagnostic tests and other sources are complete and reported accurately. ❖ Assist Principal Investigator in patient selection and clinical research study. ❖ Coordinating the work with the investigators in reporting the patient safety to the medical monitors, sponsors and regulatory body. ❖ ICF presentation, educating the volunteers, obtain inform consent and maintaining the consent related documents. ❖ Verifying the data entered on the CRF is consistent with the clinical notes supervise check-in check out of the patient. ❖ Verifying that the source documents and trial records are accurate, complete, kept up to date and maintained.
- Sr. Drug Safety Specialist at Confidential
4 years, 2 months at this Job
Completes data entry of individual case safety reports (ICSRs) from clinical trials and post marketing sources. Conducts complete clinical reviews of all domestic and foreign adverse event reports for all Acorda investigational and marketed products. Performs active follow-up, including both written and verbal communication with healthcare professionals and consumers. Exercises judgement and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, causality, listedness and reporting requirements. Interprets source documentation including relevant medical conditions, lab results and procedures to compile complete and accurate narrative summaries. Ensures consistency in the initial evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility. Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet.
- Drug Safety Specialist at Acorda Therapeutics
- Drug Safety Associate at Forest Research Institute, Inc
- Subject Matter Expert at Sentrx
- Safety Surveillance Monitor at Sentrx
4 years, 10 months at this Job
• Provide oversight for both the in-house regulatory reporting team and the vendor.
• Responsible for reconciliation of vendor submissions of regulatory reports.
• Tracking regulatory submissions in the safety database.
• Provide training when necessary related to expedited reporting rules.
• Serve as Ad hoc project manager as necessary.
• Develop and execute reconciliation reports between vendors and licensing partners.
• Create and deliver standardized/consistent/accurate data retrievals from the global safety database, both routine monthly reports and/or ad hoc queries, as requested by internal and external customers.
• Improve upon current processes such as product configuration in the global safety database.
• Develop and manage all-inclusive lists of expected events for all company products for both the Pharmacovigilance team and vendor.
• Assist in the daily management activities of the Case Processing team as a mentor and coach Serve as PV manager in manager's absence.
• Assist in preparation for any audits conducted by regulatory authorities and/or licensing partners.
• Implement, maintain, and provide regulatory/MedDRA updates to the List of Expected Events (LOEE).
• Extensive understanding of FDA, Canadian, EMA regulations and ICH guidelines to ensure adherence to global regulations.
• Collaborate with other departments on special pharmacovigilance projects and operational activities.
• Develop, execute and oversee Case Processing Inspection Readiness activities as well as data mine produced reports for accuracy.
• Identifying Data Entry errors and document these errors as feedback to CRO(s).
• Tracks metrics/goals and takes necessary action on deficiencies when required.
• Proactively identifies, evaluates, develops, and implements processes, programs and projects which result in quality and productivity, improvements to global adverse event processes and systems/databases.
• Active participation in Medical Evaluation Convention Meetings as well as within the Medical Evaluation Convention.
• Promote continuous quality improvement through identification, assessment and resolution of case processing issues.
• Assist the Signal Detection team in signal detection activities such as performing Quality Check (QC'ing) of SAS output for clinical trials and safety data base on a quarterly basis to identify any adverse events crossing the threshold value and document to ensure accuracy of information presented for Global Signal Detection Team review.
• Drafting SOP's related to case processing.
• Acted as liaison between compliance and case processing vendor in the management of market research projects and IIT's.
• Worked to assist Medical Information Unit (MIU) at Indivior in the oversight of the MIU vendor by reconciling adverse event cases processed by the MIU vendor.
- Drug Safety Specialist IV at Indivior Inc
- Drug Safety Specialist-III at Indivior Inc
- Drug safety Associate at Global Pharmatek, NJ
3 years, 3 months at this Job
- M.S in Chemistry - Chemistry
- Bachelors in Pharmacy - Pharmacy
• Ensure timely, consistent and accurate safety reporting of Adverse events in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCP), GXP and standard operating procedures (SOPs).
• End-to-end case processing including validity assessment, duplicate search, triaging, and case book-in in Safety Database Oracle Argus (8.0).
• Conduct the assessment of all serious individual adverse event case reports stemming from clinical trials, post-marketed and literature sources.
• Perform signal detection activities and quality control of key data fields, and make updates in the safety database per process conventions.
• Execute case assessment (review events; determine expectedness, review/update drug, and medical term coding, determine causality.
• Follow-up and update on ICSR if required. Proficient in MedDRA coding and accurate evaluations of serious events (causality, relatedness, expectedness) of adverse events (Serious and non-serious) and adverse drug reactions (serious and non-serious) for active trials and Post-marketing Phase.
• Literature case review and coding which include medical journals abstracts, poster presentation, full literature articles.
• Perform report deletions and case inactivation. Skilled in AE reporting system, expedited and un-expedited reporting, PADER, SAEs, SUSAR.
- Drug Safety Specialist/ Associate - Intern at Sollers Institute
- Site Coordinator/Patient Service Technician at Laboratory Corporation of America
- Resident Medical Officer (RMO) at Fair Health Hospital
- Phlebotomy Technician at Kingston Hospital NHS Trust
7 months at this Job
- Certification - Advance Drug Safety and Pharmacovigilance
- Post Graduate Diploma - PGD
- Residency (Internship) - Medicine
- M.B.B.S (Bachelor of Medicine & Surgery)- MD Equivalent - Medicine & Surgery
Fields drug safety and quality complaints and responds in accordance with FDA regulations. Maintains data sheets and associated digital records. Correlates with other departments to meet time lines and company needs.
- Drug Safety Specialist at Amneal Pharmaceuticals
- Advanced life support first responder at Yaphank fire district
- Clinical Research Coordinator at North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
- LPN- Senior Patient Care Specialist at Stony Brook Medicine (Stony Brook University Hospital)
2 months at this Job
- RN - Nursing
- Licensed practical nurse - Nursing
- Emergency medical critical care technician - Emergency medical services
• Handle the responsibilities of reviewing and processing adverse events reported.
• Perform investigational and marketed product associated SAE and AE medical narrative composition and final review.
• Assess and triages adverse event reports according to seriousness, expectedness and reportability.
• Ensure Triage of incoming cases by determining the seriousness and prioritizing case process according to the time frames stated in SOP's as per the company and regulatory requirements.
• Manages US/global adverse event mailboxes and drug safety phone line.
• Communicate via phone/fax/email with physicians, study coordinators, consumers, care givers and other parties reporting.
• Perform data entry into ARGUS data base.
• Responsible for data entry of adverse event reports from post marketing, spontaneous and clinical trials into the Argus safety database.
• Performs basic searches for open data queries within the ARGUS safety database.
• Perform medical coding using MedDRA and WHO-drug dictionaries with relevance to SAE analysis and SAE coding.
• Assess adverse events and serious adverse events against company core data sheet, investigators brochure and package insert.
• Discuss with the medical review team regarding the serious cases with events, outcome, action taken and medications.
• Perform self QC of reports.
• Acts as the primary liaison between patient support programs and the drug safety case managers
• Generates follow-up letter requests to reporters.
• Performs quality review of generated adverse event case reports in ARGUS by junior drug safety coordinator team members.
• Ensure adherence to company policies and meet departmental and regulatory requirements.
• Interact with investigational sites and internal clinical teams to provide safety expertise.
• Manages case distribution for review by drug safety manager and physician.
• Perform safety review of clinical data (CRFs) and patient laboratory documents.
• Discuss with the CRA's regarding the adverse event capturing from the clinical trial data.
• Review study specific model ICF's according to ICH/GCP criteria.
• Responsible for mentoring junior drug safety Coordinator team members.
• Performed all Corrective and Preventative Actions activities within the required timeframes to ensure compliance
• Maintain well-documented files for process reviews and issue investigations
• Coordinated the timely collection of reasons for late reporting and corrective actions to prevent future late reporting from clinical, regulatory and marketing for inclusion in safety reports to regulatory authorities.
• Assists in the preparation of PSUR's, DSUR's, annual reports to the FDA.
• Prepares and coordinates submissions of expedited drug safety reports to the FDA and international regulatory authorities.
• Assist in reviewing safety sections of clinical trial protocol, investigator brochures, informed consents, clinical study reports, annual product reviews, annual safety reports and IND annual safety reports.
- Sr. Drug Safety Specialist at Bristol-Myers Squibb
- Sr. Drug Safety Specialist at ADPI
- Drug Safety Specialist at Amneal Pharmaceuticals
- Drug Safety Associate at Shire Pharmaceuticals
1 year, 10 months at this Job
Review and process post marketing adverse event reports and product quality reports, write clinical narratives. Ensure SOP requirements and FDA reporting requirements are met.
- Drug Safety Specialist at Med Communications
- Epic Analyst -clinical applications analyst at Baptist Memorial Health Care Corporation
- Drug Safety Specialist at Bayer/ Merck Consumer Care/ formerly Schering-Plough HealthCare Products
- Surgery Clinic Manager at University of Tennessee Medical Group/Department of Surgery
7 months at this Job
- - nursing
• Processed initial and follow-up serious adverse events (SAE) from various sources including post-marketing, literature and clinical trials of various studies as per the standard guidelines within the required timelines set by company and regulatory authorities
• Perform initial check to prevent duplicate entries. Triage of incoming adverse event reports to determine seriousness for prioritization of daily workflow as well as for completeness and validity
• Review and evaluated serious adverse events for completeness and consistency with applicable FDA, global regulations SOPs and guidelines
• Create/maintain contact logs, track queries in ARGUS and request follow-up information per timelines. Perform data entry and MedDRA and WHODD coding, causality assessment, labeling in ARGUS database
• Case processing from receipt to finalization, prioritization, query generation and resolution.
• Prepare precise case narratives in accordance to standard guidelines and particularizing information in relevance to reported adverse events in ARUGS database
• Accomplished initial coding of suspect disease, adverse events and suspect/concomitant medications using MedDRA, CDD and WHO DD
• Peer reviewed the cases for accuracy before submissions to FDA, EU and other regulatory bodies
• Generate queries and work with other team members to send follow-up letter/queries to appropriate reporter, forwarding to clinical sites where appropriate
• Perform quality review - identify and report any compliance gaps related to the full quality system regulation. Interact with multiple levels of staff within PV dept. to report quality issues and gain resolution
• Review literature search articles for valid ICSR's identification based on four-minimum criteria
• Perform validation check and E2B checks for each case to minimize the errors in ARGUS.
• Generate CIOMS, MedWatch and other reports using safety database ARGUS for regulatory submission and cross reporting
• Experience performing reconciliation between safety database and clinical databases.
• Assist in safety review sections of clinical trial protocol, case investigation reports, investigator brochures, informed consents, clinical study reports, annual product reviews, annual safety reports and IND annual safety reports
• Liaised with different functional team members including project management, clinical data management, site coordinators, investigators, medical monitors and designee to address project related issues Achievements - Part of the team successfully completed a task of high volume of cases for post-marketing and clinical trial oncology study Therapeutics areas - Oncology Database - ARGUS, Medidata RAVE, EDC, Adobe, Right fax, MS office suite
- Drug Safety Specialist at United BioSource Corp
- Drug Safety Associate at Sollers
- Drug Safety Coordinator at LabCorp
- QC Analyst at LabCorp
5 months at this Job
- Bachelor's in Biotechnology/Master' - Biotechnology/Master's
- Graduate Certificate - Advanced Drug Safety & Pharmacovigilance
Excellent understanding of FDA regulations, GCP/ICH guidelines and IRB documentation.
➢ Understanding and shadowing experience in preparing relevant safety sections of the PBRER, DSUR and IB.
➢ Experience using ARGUS safety drug database.
➢ Experience in medical review and evaluation using WHO-UMC criteria.
➢ Comprehensive knowledge of global regulatory requirements for Pharmacovigilance and drug safety regulations, AE/SAE reporting guidelines and regulatory requirements in drug development.
➢ Knowledge of ICH principles and experience using drug coding conventions (MedRA, WHO DD) of AE/SAE reporting.
➢ Excellent in medical terminology and ability to summarize medical information.
➢ Expert in triaging of incoming cases, end to end case processing and NARRATIVE writing.
- Drug Safety Specialist at Life Care Nursing LLC
- Practice Manger at Saxon Medical Group
- Emergency and Trauma Physician at Hera General Hospital
- Senior Urology Assistant. / Lab Assistant at New York Urologic Institute
2 years, 5 months at this Job
- BACHELOR OF SCEIENCE
- DOCTOR OF MEDICINE - Orenburg State Medical Academy
Performed initial review of SAEs including assessment of drug-relatedness and expectedness for potential SUSARS, coding of the events using MedDRA dictionary, writing narratives, and determine license partner/IND/NDA submissions.
• Processing of serious adverse events (includes receipt, assessment, seriousness criteria / labeling) based on regulatory requirements.
• Performs data entry of SUSARS, serious adverse events data into the global safety database.
• Review literature to identify cases that will need to be entered into the global database.
• Complete coding of adverse events and medications within guidelines set by MedDRA and WHO-drug (medical coding).
• Played an important role in migration of Argus database from CRO.
- Drug Safety Specialist at Acorda Therapeutics
- Drug/Clinical Safety Associate at
- Drug safety associate II at Merck
- Drug Safety Associate at Jazz Pharmaceuticals
5 years, 4 months at this Job