Assist in timely receipt and book-in of clinical and spontaneous SAEs. This includes monitoring the CSPV e-mailbox (and providing backup as needed for the CSPV-Clinical e-mailbox as well as the incoming CRO cases) for incoming cases, booking cases into ARISg, checking for duplicates, and creating and / or locating case files.
• Perform SAE reconciliation for safety data exchanged among the license partners.
• Perform monthly post marketing search of ARISg database for medical affairs for all DSPD marketed products.
• Post clinical line listings to the clinical database (CDR), including converting Excel files to SAS.
• Participate in safety database validation activities, which may include dry running test scripts, providing feedback on test scripts and database findings, and performing formal validation in accordance with Good Documentation Practices.
• Send follow-up letters for initial and subsequent cases.
• Develop case folders and forward to drug safety specialist for review.
• Create and run NDA PADER'S.
• Perform Validation tasks for database change controls.
• Subject matter expert for ARISg database.
• Assist with projects upon request corrections, deletions.
- Drug Safety Specialist at Daiichi Sankyo Pharma Development
- Drug Safety Associate at Medarex, Inc
- Drug Safety Coordinator at Novartis Pharmaceuticals
- Clinical Data Associate II at CMed Inc
7 years, 11 months at this Job
- B.S. - Psychology Pending
- A.S. - Biology
§ Book-in, designate and triage ICSRs received via mail, e-mail, fax, E2B, LAM, or Gateway Transmissions in Argus § Identify potential product and device complaints for incoming ICSRs § Ensure all necessary data entry conventions are complete and adverse events are properly entered based on MedDRA coding and WHO-Drug dictionaries § Responsible for case quality review by identifying and query critical missing information to register cases, as well as perform duplicate checks before registering reports within 2 business days § Developed a working knowledge of FDA, international pharmacovigilance and clinical safety regulations
- Drug Safety Specialist at Gilead Sciences
- Pharmacist Graduate Intern/Pharmacist at Walgreens
- Class of 2019 Mentor at The Johns Hopkins Hospital
- at The Johns Hopkins Hospital
4 months at this Job
- Doctor of Pharmacy - Pharmacy
- Bachelor of Science in Chemistry - Chemistry
- Drug Safety Specialist at Alkermes
- Lead International Nurse Case Manager at On Call International
- Drug Safety Case Manager at Genzyme Corporation
- Emergency Department Tertiary Care Leader at Lahey Clinic Medical Center
5 years at this Job
- B.S. - Health Care Administration completion
Complete data entry of individual case safety reports from clinical trials and post marketing sources into the Argus database. Conduct complete clinical reviews of all domestic and foreign adverse event reports for all Acorda investigational and marketed products. Ensure consistency in the initial evaluation and assessment of adverse event reports and source documentation for completeness accuracy and legibility. Perform active written and verbal follow-up with healthcare professionals and consumers. Interpret source documentation including relevant medical conditions, lab results, and procedures to compile complete and accurate narrative summaries. Exercise judgment 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. Review all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet. Produce Clinical Safety Queries as needed for clarification of reports. Serve as a Safety Liaison contact to other departments and Acorda licensing partners. ~ Interact on a regular basis with Clinical Project Mgrs, Case Processing Mgrs, and Medical Affairs to identify process improvement strategies and communicate project status updates. Interact on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues.
- Drug Safety Specialist at Acorda Therapeutics (Remote)
- Pharmacovigilance Case Specialist at Bayer Healthcare Pharmaceuticals
- Clinical Research Associate at Merck
- Drug Safety Associate Manager at Merck
3 years, 7 months at this Job
- Bachelor of Science in Nursing - Rutgers
- - Medical
- - Clinical
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, 8 months at this Job
• 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
9 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
Manage and oversee drug safety and pharmacovigilance processes for multiple client projects. Manage and oversee 10-15 direct reports to maintain compliance and quality for client projects. Maintain a strong working knowledge of ICH, GCP, and relevant regulations and guidelines. Recommend, develop and maintain SOPs, Working Instruction Documents and any necessary forms for internal Drug Safety processes. Ensure that adequate internal processes and training are in place for proper handling of safety information received by company.
- Drug Safety Manager at Neumann University
- Adjunct Instructor at Neumann University
- Project Manager at Pharmacovigilance - United BioSource Corporation
- Safety Surveillance Scientist at Auxilium Pharmaceuticals, Inc
5 years, 1 month at this Job
- Doctor of Education - Organizational Leadership
- MBA - Business Administration
- Diploma - Practical Nursing
• 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
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
• Process case-related information including interpretation of medical conditions, lab results, and procedures.
• When required, perform timely and accurate triage of adverse event reports, complaints, & inquiries from physicians, pharmacies, consumers and sales reps.
• Correspond with health care professionals, consumers, and company personnel regarding safety issues with marketed products.
• Correspond and interface with CRO's regarding collection of safety information for development products when needed.
• Responsible with reconciliation activities with internal departments and external partners as needed.
• Assist senior management with Project-related activities necessary to build and develop the Pharmacovigilance Infrastructure.
• Ensure timely preparation & submission of reports to regulatory agencies in accordance with applicable regulations - including US PADER.
• Participated in Signal Detection, gathering and collecting datas, assisted MD in reviewing cases if true signal was detected.
• Review literature citations weekly for appropriate reporting and collection of safety information for both marketed and development products when needed.
• Responsible in training staff in the Triage process, Case Process, Case Review and Submission to FDA
• Participate in set-up and maintenance of ADE workflow, implementation of department policies, work conventions and development and review of SOPs. E2B weekly reports for non -serious cases making sure no serious cases were missed.
• Participated in the recent FDA Audit in the Pharmacovigilance and Regulatory Department with successful outcome.
- Senior Drug Safety Associate at Onpoint Clinical Solutions
- at Greenkey Resources LLC
- Drug Safe Associate at Helsinn Therapeutics
- at Aerotek Inc
1 year, 1 month at this Job
- Bachelor of Science of Nursing - Nursing