• Understanding and using FDA, EU-EMA, ICH regulations for drug safety and pharmacovigilance.
• Develop advance knowledge of the role and responsibility as a Drug Safety Associate.
• Practice the process of triage, data entry, medical review, statistical analysis and reporting the Oracle Argus software.
• Detailed training in Medical narrative writing for SAE reports.
• Expertise in Regulatory report writing like: CS, PSUR, and SUSAR.
• Conducted Pharmo-epidemiological Phase IV studies.
• Evolved and implemented Risk Management Practice.
• Ensured success in Pharmacovigilance audits.
- Drug Safety Associate Trainee at Clinical Research Academy of America
- Research Associate/ Regulatory Affairs Analyst at Reckitt Benkiser
- Process Chemist/ Inventory Specialist at The Neostrata Company
- Formulation Chemist at Johnson & Johnson
2 years, 10 months at this Job
- B.S. - Chemistry
Managed and tracked receipt of initial and follow-up safety reports from global clinical trial sites. Performed patient registration for clinical trials by reviewing medical records. Received, processed, and evaluated adverse events and investigational product complaints. Managed and tracked compliance of pharmacovigilance agreements, and maintained files for SAEs, adverse event reports and product complaints in an electronic database as well as in hard-copy folders. Supported and participated in audit and inspection preparedness activities. Interpreted and applied current department SOPs as well as FDA and international guidelines and regulations. Escalated serious adverse event complaints and any drug safety-related issues to the attention of management and medical monitor as necessary. Coordinated data safety monitoring committee members and meetings. Compiled data and created presentations for quarterly medical monitoring reports. Generated and assembled data submitted to the FDA regarding protocols and correspondence. Provided on-the-job training, education and mentoring for staff as appropriate. Created queries for clarification and assisted in resolving database discrepancies and end-of-study adverse event reconciliation. Entered data from individual case safety reports into Oracle Argus Safety database and managed open cases to closure. Helped in generating and evaluating required regulatory expedited and periodic reports for submission to the FDA, including appropriate MedDRA coding of adverse event terms and the compilation of narrative and medical assessments of expedited reports as part of periodic reports.
• Promoted to Drug Safety Associate II, specially created to reflect doubled workload and responsibilities.
• Created new drug safety documents for SAE assessments.
• Created new SOPs for drug safety review.
- Drug Safety Associate/Drug Safety Associate II at NEWLINK GENETICS CORPORATION
- Clinical Administrative Assistant/Safety Assistant at
5 years, 6 months at this Job
- Liberal Arts
• Responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies
• Conduct assessment of serious and non-serious Individual Case Safety Reports (ICSRs) and medical device reports associate with the use of Otsuka products from all sources (spontaneous/clinical trials/literature).
• Review source documentation and assess cases for accuracy and completeness
• Executes case assessment (review events, determine expectedness, review/update drug and medical term coding, determine causality)
• Generated concise, accurate, and well-written case narratives procured from relevant information in form of various source documents
• Conduct periodic reconciliation of safety data between the drug safety database and the clinical trial databases
• Supervise the periodic reconciliation of safety report information between the drug safety database and local PV representatives
• Track and provide status updates to project managers upon request
• Work closely with medical reviewers, Safety Data Management, Quality group and other department personnel
• Organize and actively participate in safety review meetings, if required
• Assist PV management in the oversight of vendor supported ICSR processing
• Act as liaison internally and with external pharmacovigilance providers (CROs) and Business Partners on Drug Safety and Pharmacovigilance case management issues
• Support PV management in investigation, root cause, corrective and preventive actions related to internal and external PV associated CAPA findings
• Knowledge and trained in Regulatory Submission process
• Participate in training activities related to ICSR case handling
- Drug Safety Associate at Otsuka Pharmaceutical
- Safety Surveillance Associate at Pfizer
- Senior Drug Safety Specialist at Mylan Pharmaceuticals
- Pharmacy Technician at CVS Pharmacy
3 years, 5 months at this Job
- Doctor of Pharmacy - Pharmacy
• Data entry of individual case safety reports (ICSRs) into Argus Databases
• Perform quality checks of ICSRs
• Code adverse events and drugs using MedRA and WHO dictionaries
• Write case summaries and CIOMS
• Use Electronic Data Capture to initiate queries to obtain missing case information
• Assist to ensure that safety reports comply with both internal and regulatory timelines
• Ensure accuracy and completeness of data entered in the databases
• Integrated the use of Argus Safety to perform case processing and data gathering tasks
• Enhance the coding of adverse event terminologies using MedDRA and WHO Drug Dictionary
• Monitor adverse event electronic mailbox for receipt of new information
• Reduce data consistency errors relating to pharmacovigilance data
• Process all incoming cases in a timely manner and ensured timely case assessment
• Accelerate the processing of adverse event programs and pharmacovigilance developments
• Achieve compliance with applicable regulatory requirements and Standard Operating Procedures
- Drug Safety Associate at Sollers College
- Medical Doctor at Federal Medical Center
- Pharmacist Assistant at Georgetown Public Hospital
9 months at this Job
- Associate degree - Nursing
- Graduate Certificate in Advanced Drug Safety & Pharmacovigilance - Advanced Drug Safety & Pharmacovigilance
- Bachelor of Medicine - Medicine and Surgery (MBBS)
- Bachelor of Science in Applied Biochemistry - Applied Biochemistry
• Process Individual Case Safety Reports (ICSR) for marketed and investigational products from all sources.
• Manage assigned ICSR workflow to ensure that all case processing activities from receipt through regulatory submission are carried out in accordance with relevant regulatory requirements and established company processes.
• Report Triage adverse event using medical and regulatory expertise to determine seriousness, labeling and reporting status.
• Perform complete data entry of adverse event reports (AER) into the electronic drug safety database.
• Draft individual case summary reports and wrote concise case specific narratives as per company/product conventions
• Submit ICSR's to the regulatory authorities in a timely manner.
• Perform Medical coding using MedDRA and WHO drug/CDD
- Drug Safety Associate at Endo Pharmaceuticals PA
- Clinical Research Assistant at Alpha Neurology Staten Island NY
- Junior Data Analyst (Case Processing Associate) in Pharmacovigilance department at Aurobindo Pharm Hyderabad
2 years, 4 months at this Job
• Creating Case and entering relevant case information into the global pharmacovigilance database to store and track all reported adverse event information.
• Register adverse event information and scan, import all adverse event source documentation into the ICSR within the electronic safety database
• Perform triage of potential adverse reports to assess seriousness of case and search of duplicate cases
• Process serious adverse event (SAE) and non-serious individual adverse event reports from post marketing and clinical studies.
• Accurate data entry from source documents and perform medical coding using MedDRA and Drug name coding using WHO DD.
• Obtain follow-up information via mail or telephone from healthcare professionals and consumers.
• Draft individual case summary reports and write concise case specific narrative.
• Perform Self Quality Checks to validate the data.
• Analyzed cumulative investigational and marketed product adverse event reports for inclusion in Periodic Safety Update Reports
• Monitor electronic mailboxes to ensure timely acceptance of Adverse Event (AE) Reports to perform data entry into databases, as needed
• Submitted ICSR's to the regulatory authorities (RA) in a timely manner
• Attend Internal meetings and summarize weekly documentation for studies.
- Drug Safety Associate at Janssen
- Drug Safety Associate at Endo Pharmaceuticals Inc
- Staff pharmacist at Wood lane Pharmacy
- Staff Pharmacist at Walgreens Pharmacy
1 year, 7 months at this Job
• Verify the validity of a case by making sure Minimum safety information (MSI)
• Identify duplicates and Incorporate physician input, append case files and perform in-process quality review for case receipt
• Enter preliminary and follow-up information from source documents into the global adverse event database ARGUS
• Request follow-up information from consumers, and health care professionals as and when required, ensuring global and local SOP timeframes
• Responsible for coordinating and performing adverse event (SAE/AE/ AE reports from clinical studies and spontaneous post-marketing reports)
• triage, data entry into adverse event database assign MedDRA/ WHO-drug dictionary review of entered cases for quality, consistency and accuracy, follow-up with reporter and/or associated HCP, tracking of reports, and reporting activities
• Determine the listedness of adverse events using safety documents, which include IB and PI.
• Perform ICSR quality assurance reviews for data integrity and communicate findings
• Assure completeness and seriousness which includes Medical monitor's evaluation and assessment for relatedness and expedited reporting.
• Processing clinical trial case SAE reports, both serous and non-serious cases, assessed SUSAR cases.
• Applying Standard Guidelines & requirements (GCP/GPV/ICH/CIOM/FDA)
• Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues
• Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans
• Provide input in multidisciplinary team meetings and relaying information to PV management.
• Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective
• Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices
• Participate in Risk Management Strategy
- Drug Safety Associate (Remote contractor) at Sollers, NJ
- Clinical Research Associate at Lady Reading Hospital
- Assistant Professor Work Study Program at Hebei North University Hospital
- Physician at Internal Medicine
1 year, 1 month at this Job
- M.D. degree - Medicine
• Perform manual triage of non-serious cases to ensure the accuracy of that determination with the potential to upgrade to serious for higher level medical review.
• Create comprehensive narratives procured from relevant, related information from various source documents.
• Triaged every report to confirm the validity of the case and decide on the timelines in accordance with the regulatory requirements for submission and company specific standard operating procedures
• Completing full case information on the database ensuring quality by accuracy and completeness of each case
• Preparation of case narratives, in accordance to CIOMS V, particularizing information that is medically relevant to the adverse events reported
• Receiving, processing and follow up of Adverse events(AEs) and Serous Adverse events(SAEs) reports
• Coding of medical history, drugs and reported adverse event terms in safety database using medical dictionaries (MedDRA) and assessing expectedness/listedness of adverse event according to CCDS for the product.
• Review of previously entered data and completion of data entry including writing adverse event case narrative summarizing the essential details of the case.
• Processing and reporting of spontaneously reported adverse drug reaction as well as company sponsored clinical trials according to the guidelines and SOPs documented by the company to the health authorities within the reporting timelines.
• Accurate coding of incoming serious and non-serious adverse events using MedDRA terminology.
• Coding of medical terms using standardized medical dictionaries and drugs using WHO Drug Dictionary.
• Assess follow-up, lock, and distribute/archive non-serious cases.
• Maintain continuous knowledge expertise in local and global requirements for safety reporting.
• Ensured timely coverage of incoming cases to Regulatory Authorities.
• Participating in the aggregate report preparation with the study director.
- Drug Safety Associate at Syndax Pharmaceuticals
- Doctor Assistant at Private Physicians Clinic
2 years, 2 months at this Job
- Doctorate - medicine ( M.B.B.S.)
- USMLE - Step 1 & Step 2 CS
• Monitored drug safety inbox to process cases from receipt to closure in accordance with ICH and USFDA Regulatory guidelines
• Performed Case triaging and Data Entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug and concomitant medications and adverse events into the Argus Safety Database using MedDRA and WHO drug dictionaries
• Assessed cases for Seriousness, Expectedness and Causality
• Proficient in writing case narratives
• Performed Quality Review to ensure accuracy and completeness within the specified timelines
• Setting up follow-up queries to obtain missing case information and clarifications
• Filing PQCs(Product Quality Complaints) associated with adverse events
• Assisted with AE/SAE reconciliation prior to database closure
- Drug Safety Associate at Sollers, NJ
- Pharmacist at IND Consulting
- Pharmacist (Retail) at Easy Pharmacy and Surgicals, NJ
- Medical Solutions Consultant at Kairos Content Solutions
7 months at this Job
- Certification - Advanced Drug Safety and Pharmacovigilance
- Certificate - Clinical Research and Drug Discovery
- Masters in Pharmacology and Toxicology - Pharmacology and Toxicology
- Bachelors in Pharmaceutical Sciences - English, Hindi
• Complete medical Data Entry in the Global Safety Database including the generation of medical narratives.
• Perform Peer Quality Control to ensure completeness, accuracy, and overall high quality of AE data entered into the Safety Database.
• Participate in data clean up activities in support of the GSD migration.
• Execute User Assistance Testing (UAT) to ensure functionality of the new database.
• Assist in testing and executing change request post database migration.
• Responsible for the timely assessment and processing of adverse events for both post-marketed (all company products excluding Tysabri) and Investigational Medicinal Products (see above oncology products) in a validated safety database (ARISg). This includes assessment, data entry, narrative writing, and coding; requiring a strong medical/working knowledge across various TA's, as well as a strong understanding of current or conventional treatments.
- Biogen (Senior Drug Safety Associate) at See resume
- U.S Drug Safety and Quality Assurance/Drug Safety Scientist at EMD Serono
- U.S Medical Info Specialist at EMD Serono
- Drug Safety Associate at Sepracor Corporation Headquarters
3 months at this Job
- PharmD - Pharmacy
- Bachelor in Pharmacy Sci - Pharmacy Sci
- - Pre-Pharmacy