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0-5 years of experience
Entered preliminary and follow-up information received via mail, telephone, and electrical source documents into a global electronic adverse event database (ClinTrace).
- Reviewed, processed, coded, and submitted serious and non-serious adverse event reports for spontaneous and sponsored studies, in compliance with global regulations and compliance timelines.
- Utilized medical terminology, MedDRA coding terms and obtained detailed information in prevention of quality assurance discrepancies.
- Prepared narratives for MedWatch (FDA 3500A) and CIOMS forms for domestic and international cases.
- Logged reports for tracking of contrast media adverse events in lotus notes application (WALNOT) within the Drug Safety and Pharmacoepidemiology (DSP) Unit.
- Contributed to the improvement of the electronic safety database and filing system by maintaining filing system integrity for report hardcopy, and performing accurate database searches.
- Assisted in the preparation of SOPs, Aggregate Reports (PSURs), preparing line listing reports and summary tabulations tracked with document control including training materials, and maintained currency of SOPs.
0-5 years of experience
Case Processing: – performed case receipt, case triage and processed adverse event using Argus.
- Performed follow-up via telephone contact with health care professionals
- Coding relevant medical terminology, composed descriptive narrative and generated advanced condition queries.
- Quality control check of adverse event for accuracy and completeness.
- Prepared safety reports and utilized regulatory and medical knowledge to assess claims.
0-5 years of experience
Entered appropriate data in Oracle Clinical database according to SOPs, selected appropriate event terms in MedDRA and wrote narratives summarizing the events.
- Reviewed spontaneous case reports concerning adverse events and serious adverse events to ensure accurate data capture according to departmental SOPs.
- Reviewed and updated clinical trial case report forms concerning serious adverse events for completeness and accuracy.
- Conducted follow-up queries with clinical investigators regarding incomplete or unclear data.
- Performed secondary and auxiliary data review and SAE reconciliation.
0-5 years of experience
Directed collection, data entry, coding, routing, follow-up, and timely reporting and submission of spontaneous, foreign and literature safety information in compliance with FDA regulations.
- Trained and mentored new drug safety associates, providing supervision and teaching key skills in Drug Safety.
- Handled initial and follow-up pharmacovigilance transactions from consumers, health care professionals, and attorneys, as necessary, in accordance with Forest policy and procedures.
- Assigned and completed expedited cases to ensure regulatory and client deadlines were met.
- Informed appropriate staff of delayed, missing or incomplete items; established follow-up procedures and completed all transactions in a timely manner.
- Minimized risk through active collaboration with Quality Standards and interfacing with management as needed.
- Expertise in safety system experience and case processing, interfacing with teams formed to assess the continuing safety profile for the compound or product.
6-10 years of experience
Reported adverse events to FDA according to ICH guidelines related to (postmarketed) litigation drugs/vaccines. Perform void/consolidations, mixed and split document case reporting using MedDRA coding, WHO-DRL, using Argus.
- Authored safety narratives and prepared adverse event reports for medical review and submission to regulatory authorities
- Managed timely case processing to ensure PSUR deadlines
- Reconciled reports of product quality complaints associated with adverse events and all other spontaneous adverse events with Quality Assurance and Medical Information departments
- Requested follow-up information concerning adverse event reports as appropriate
- Triaged and analyzed adverse event information for entry into the adverse event tracking and reporting system
- Coded and classified adverse event reports according to regulations and department SOPs
0-5 years of experience
Performed case triaging and case processing.
- Performed the initial review of ancillary documentation accompanying Individual case Safety reports.
- Assessed case report for seriousness, causality and expectedness.
- Collected, processed follow-up, analysis, and regulatory reporting of adverse event and serious adverse events for marketed products and investigational products by using Arisg database.
- Managed case related information including lab results, and procedures as well as compiled complete narrative summaries.
- Maintained consistency of safety assessment.
0-5 years of experience
Collected, documents, and processed adverse event (AE) reports from clinical trials adhering to Standard Operating Procedures.
- Prepared clinical narrative summaries for ‘Adverse Event’.
- Performed active follow-up via telephone contact with consumers and healthcare professionals.
- Ensured timely coverage to Regulatory Authorities and pharmacist.
- Participated in preparing safety reports and maintained clinical databases.
- Perform Medical review of Individual cases safety reports to determine Relatedness, Causality assessment, case finalization and Reportability.
- Wrote and corrected Narratives for FDA submissions.
- Liaised with assigned Physicians in Drug Safety, Clinical Science and/or MedSA to ensure that appropriate medical review and assessment is provided for assigned case reports
0-5 years of experience
Entered and validated adverse event related information in drug safety database for investigational and post-marketing products.
- Created comprehensive narratives procured from relevant, related information from various source documents.
- Generated requests for follow-up information.
- Provided follow-up on adverse event cases by preparing, sending out and tracking queries to reporters.
- Managed Case-related information including interpretation of medical conditions, lab results, and procedures.
- Prepared all critical study related documents, performed regulatory and ethical submissions and communicated with relevant authorities.
- Review of all cases in accordance with GCP and other regulatory guidelines.
- Collaborated with internal departments and investigative clinical research sites to ensure compliance with safety processes.
- Maintained working knowledge of regulatory strategy and current regulations in the pharmaceutical industry.
6-10 years of experience
Adhered to and enforced federal guidelines.
- Performed clinical assessments of medical charts in adverse events.
- Carried out detection and analysis.
- Generated commentaries and reported to federal authorities.
- Implemented strong clinical communication skills and use of computerized systems.
0-5 years of experience
Triage of incoming cases to determine seriousness for prioritization of daily workflow.
- Processing of adverse events (includes receipt, assessment of Listedness, seriousness criteria / labeling, case prioritization and request follow-ups) based on regulatory requirements.
- Performed the initial review of SAEs including assessment of drug-relatedness and expectedness, coding of the events using MedDRA dictionary and the writing narratives.
- Reviewed source documentation, assessing cases for reportability, accurate data entry, and quality check.
- Written clinical narrative summaries independently for SAE/AE reports from clinical studies and spontaneous post-marketing reports and formulated follow-up information requests.
- Performed active follow-up via telephone contact with consumers and health care professionals.
- Ensured timely reporting of SAEs/AEs to Regulatory Authorities, and cross-reporting to pharmaceutical partner(s).
0-5 years of experience
Received and entered adverse drug events, as well as follow-up from vendors, clinical trials, and spontaneous complaints from consumers, and healthcare providers into both argus and arisg databases.
- Managed data from both postmarket as well as clinical trials according to specific regulations and guidelines
- Responsible for initial triaging of cases coming from the US drug safety intake.
- Reviewed, ranked, verified, processed, and documented case-related information: event terms, validity, seriousness, special scenarios, timeline, accuracy and consistency effectively using both MedDRA coding as well as WHO-DD to report necessary items.
- Reconciled with all internal and external reporters accurately and promptly
- Handled determination of local submission of individual, and where appropriate, aggregate safety reports
- Proficiently wrote and, where necessary edited the case narratives of each adverse drug event received
- Liaised with key partners, locally and other stakeholders regarding safety data collection and data reconciliation
- Determined reportability of scheduled reports, always ensuring adherence to regulatory requirements, as well as internal SOPs
6-10 years of experience
Responsible for comprehensive adverse event report case management and safety issues in compliance with corporate Sop’s and worldwide regulatory timelines.
- Processed adverse experience reports for both marketed and investigational products for the Food and Drug Administration and for worldwide regulatory agencies. Duties included tracking, reviewing, coding, computer entry, preparation of final reports and the submission.
- Reviewed literature articles for Merck products. Assessed the need for further processing or the need to send the articles to contacts in other countries for data entry in order to meet strict timelines.
- Requested documents from numerous departments, processed relevant AE information and submitted multiple NDA submissions within required timelines including VARIVAX, MMR II and PROQUAD.
- Validated lot numbers when available and emailed other sites worldwide to obtain US lot equivalent numbers when necessary.
- Performed end of study unblindings.
- Informed the team monthly on SOP updates.
0-5 years of experience
Processing of adverse events (Triage process) data for investigational and spontaneous AE reports.
- Recording of questions, adverse events and complaints from consumers and reporters.
- Reviewing, evaluating and summarizing information in a written document and initiating investigations if required.
- Creating of new cases, searching for duplicate cases and extract information from the database.
- Generating of the case narratives and coding of events in MedDRA, and generation of Medwatch.
- Using internet or electronic databases to mail the inquiries and appropriately respond and to search for the published literature on the company products.
- Adverse event report processing (for pre and post marketed studies) within 24 hour limitation to meet with the regulatory requirements for FDA and ICH guidelines etc.
0-5 years of experience
Documented and processed Serious Adverse Event Reports within company and sponsor timelines in accordance with FDA regulations
- Utilized clinical record data to create detailed safety narratives for serious adverse event reports for submission to pharmaceutical sponsor and FDA
- Issued extensive written queries and liaised with investigational sites to obtain follow up information for completion of reports
- Created project-specific training materials utilized in the training of new team members
- Provided education of study coordinators/CRAs in SAE reporting guidelines according to FDA/Sponsor conventions
- Managed SAE report processing for over 200 clinical sites in international phase IV clinical trial for anemia/chronic kidney disease/diabetes
- Liaised with Sponsors/Project Managers to establish and maintain SAE reporting system for over 25 Phase I-II Clinical Trials
- Served as key point of contact for study coordinators in SAE reporting questions
- Proficient in use of ARIS-g Safety Database
0-5 years of experience
- Performed initial safety review to ensure drug safety.
- Supported clinical operations team on technical matters.
- Created well written regulatory reports on each case study.
- Conducted follow-up querying with reporter to clarify data for accuracy as well as capture additional relevant data.
0-5 years of experience
- Processed adverse event complaints in Argus Drug Safety Database
- Performed telephone intake and follow-up with consumers
- Interfaced with all levels of health care professionals to assess adverse event cases
- Assisted with the daily functions of the Department Coordinator; i.e. Reviewed and reconciled incoming AE/QD information to determine required action, acknowledged receipt of complaint information from applicable partners, forwarded complaints received related to non-Watson products to the appropriate company, organized and managed the file room
- Assisted with cataloging literature articles in online database (EOS International)
0-5 years of experience
Experience in preparation, interpretation, and data entry of adverse events reports into the global safety database (Argus versions 5.0; 5.2) for global distribution.
- Good working knowledge of Clinical trials data like Demographic data, discrepancy, adverse events, serious adverse events, Laboratory data, vital signs.
- Data management skills like Merging, Handling missing values, Reading Raw data files, creating data structures, Accessing and managing data, Appending, Concatenating and interleaving of SAS data sets.
- Process and evaluated foreign and domestic Individual Case Safety Reports(ICRs) of Marketed and Non-Marketed drugs for submission as per regulatory requirements.
- Assisted in developing, editing, organize, submission of data sets to regulatory bodies.
- Oversee confidential data bases for clinical information as well as data from selected Case Report Forms, research studies and administrative projects.
- Triaged case base for Seriousness/Non Seriousness/Fatality of Individual Case Safety Reports (ICSR)
- Generated CIOMS/Med watch for submission and report to concern regulatory bodies..
- Subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; liaised with key partners (e.g., BUs, License Partners) regarding safety data collection and handling
0-5 years of experience
Processed adverse event reports in accordance with Standard Operating Procedures and guidelines.
- Prepared narrative summaries.
- Performed quality review of peer’s reports.
- Developed expertise on all assigned products.
0-5 years of experience
Processing, collection and follow-up on post-marketing spontaneous and solicited adverse event reports for submission within ICH and local authority requirements.
- Performance of risk and quality functions on AE reports, including manual coding, as needed.
- Prioritize workload for products and liaise with Safety Associates and others involved in workflow to ensure timely
- Production and review of periodic annual reports for post-marketing surveillance.
- CoTherix was acquired by Actelion, Inc in January 2007.
0-5 years of experience
Maintain accurate and thorough documentation in order to ensure good audit practice in compliance with GCP, GMP, ICH, Federal US and any pertinent local regulations.
- Conduct quality reviews of non-serious cases in order to ensure quality and consistency of information.
- Performed Duplicate Searches, Triage, Registry and Case Processing of serious and non-serious adverse event reports adhering to Standard Operating Procedures
- Triage review and follow-up assessment of safety case reports of ICSRs determine seriousness and assess causality.
- Assist with conducting final Medical Review of ICSRs.
- Case assessment and processing in the electronic database according to established department convention
- Ensure compliance with regulatory timelines for individual expedited case reports submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
- Complete timely diligence, review and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.
- Has maintained functional and project management responsibilities surrounding serious adverse event reporting, narrative writing, safety database reconciliation (Oracle AERS, ARGUS and ARISg), E2B safety data migration and trained in signal detection, risk management and global regulatory reporting.
- Coordinated trials in an academic setting and directed all regulatory and safety aspects of these clinical studies including submissions of ADR and SAE reports and annual reports to the IRB, and FDA.
0-5 years of experience
Maintain accurate and thorough documentation in order to ensure good audit practice in compliance with GCP, GMP, ICH, Federal US and any pertinent local regulations.
- Conduct quality reviews of non-serious cases in order to ensure quality and consistency of information.
- Performed Duplicate Searches, Triage, Registry and Case Processing of serious and non-serious adverse event reports adhering to Standard Operating Procedures
- Triage review and follow-up assessment of safety case reports of ICSRs determine seriousness and assess causality.
- Assist with conducting final Medical Review of ICSRs.
- Case assessment and processing in the electronic database according to established department convention
- Ensure compliance with regulatory timelines for individual expedited case reports submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
- Complete timely diligence, review and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.
- Has maintained functional and project management responsibilities surrounding serious adverse event reporting, narrative writing, safety database reconciliation (Oracle AERS, ARGUS and ARISg), E2B safety data migration and trained in signal detection, risk management and global regulatory reporting.
- Coordinated trials in an academic setting and directed all regulatory and safety aspects of these clinical studies including submissions of ADR and SAE reports and annual reports to the IRB, and FDA.
0-5 years of experience
Maintain accurate and thorough documentation in order to ensure good audit practice in compliance with GCP, GMP, ICH, Federal US and any pertinent local regulations.
- Conduct quality reviews of non-serious cases in order to ensure quality and consistency of information.
- Performed Duplicate Searches, Triage, Registry and Case Processing of serious and non-serious adverse event reports adhering to Standard Operating Procedures
- Triage review and follow-up assessment of safety case reports of ICSRs determine seriousness and assess causality.
- Assist with conducting final Medical Review of ICSRs.
- Case assessment and processing in the electronic database according to established department convention
- Ensure compliance with regulatory timelines for individual expedited case reports submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
- Complete timely diligence, review and processing of adverse event reports as requested in order to fulfill all regulatory reporting obligations.
- Has maintained functional and project management responsibilities surrounding serious adverse event reporting, narrative writing, safety database reconciliation (Oracle AERS, ARGUS and ARISg), E2B safety data migration and trained in signal detection, risk management and global regulatory reporting.
- Coordinated trials in an academic setting and directed all regulatory and safety aspects of these clinical studies including submissions of ADR and SAE reports and annual reports to the IRB, and FDA.
0-5 years of experience
Triage of incoming adverse event reports for completeness, legibility, and validity.
- Assess events appropriately for seriousness, causality and expectedness, and follow up with sites and sponsors for FDA required information.
- Responsible for adverse event, drug coding and writing case narratives.
- Assist Medical Directors with medical monitoring activities including collection and review of endpoint packages, patient eligibility issues, protocol violations, and review of study specific Model Informed Consent Forms.
- Work within teams of Medical Directors/Safety Physicians, Medical Project Managers, sponsors, Principal Investigators and their site staff.
- Participate in internal and external team meetings and project specific training sessions.
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[Drug Safety Associate]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
