Sana Hameed ad2b88@r.postjobfree.com Mobile: 848-***-****

Summary:

Profession with extensive experience in patient care and medical research with skills in drug safety, pharmacovigilance focused on adverse event reporting of investigational and post-marketed pharmaceutical drugs. Proficient in case processing, validity assessment, triaging, duplicate search, Case Book-in, and adverse event (SAE and AE) coding using MedDRA. Professional with a high degree of urgency, self-motivation and have a strong work ethics. Strong ability in time management, attention to detail, accuracy with ability to prioritize and organize multiple tasks by handling both triage and case processing teams simultaneously. Quick Learner organized and detail- oriented.

Skills:

●Experienced in case processing activities for adverse events from receipt to case closure in accordance with ICH-GCP and USFDA regulatory guidelines. Focused on initial case assessment to determine validity and triaging cases to prioritize seriousness.

●Data entry of Individual Case Safety Reports (ICSRs) into Argus Safety Database and performing quality check of ICSRs.

●Understanding of Drug Safety Surveillance and the FDA Adverse Event Reporting System (FAERS).

●Experienced in adverse event reporting using the voluntary MedWatch 3500 (for HCP and consumer) and MedWatch 3500 B (consumer-friendly version of 3500) as well as the mandatory reporting forms MedWatch 3500 A and CIOMS.

●Proficient in consistent coding of diseases, adverse events, and medication according to the Project-specific coding conventions.

●Proficient in serious adverse event (SAE) and non-serious adverse event reports, both individual and aggregated reports from post marketing and clinical studies.

●Accurately entered data from source documents/ call center reports/ medical reports and proofread for completeness, accuracy and consistency of information.

●Good knowledge of applicable global, regional, local clinical research regulatory requirements including Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines.

●Completed quality review for adverse events (AEs), serious adverse events (SAEs), and serious unexpected serious adverse reactions (SUSARs).

●Assisted with AE/SAE reconciliation prior to database closure.

●Hands on experience with data entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Argus Safety Database and performing quality check of ICSRs

●Experienced in writing case summaries of gathered information into a concise clinical narrative, assessing causality, and writing CIOMS comments including coding adverse events and drugs using MedDRA and WHO Drug Dictionary.

●Generated queries to obtain missing case information and clarifications if required in Electronic Data Capture.

●Hand on experience on Oracle Argus safety and Trackwise (TW) from case booking to case processing.

●Good knowledge of GCP, IRB, FDA, SOP, AE, SAE, CRF, ICH, IND, and CRF guidelines.

●Expert in coding using MedDRA, WHO Drug dictionary.

●Safety database case processing experience, Oracle Argus and Aris-global safety database.

Work Experience:

Drug Safety specialist III (ICSR reviewer) Sept 2021- Present

Astellas Pharma

North Brook, IL.

●Medical review of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Argus Safety Database and performing quality check of ICSRs Queries related to safety events are reconciled with data management team and resolved timely.

●Data entry of Individual Case Safety Reports (ICSRs) including general information, patient information, medical history, laboratory data, suspect drug, concomitant medications, and adverse event coding into Argus Safety Database and performing quality check of ICSRs

●Performing Coding review of relevant Medical Terminology, Writing Narratives for MedWatch (FDA 3500A) and CIOMS forms for domestic and international cases.

●Prepared clinical narratives and independently assigned MedDRA coding to any adverse events.

●Ensured accuracy of coding, which includes selecting appropriate event terms in MedDRA. Coded all adverse event terminology, other medical information, and drug information in safety database utilizing MedDRA and WHO drug dictionaries, in accordance with coding policies and standards.

●Performed case Prioritization/Triaging based on seriousness of adverse events in accordance with SOP guidelines.

●As a case processor entered full case information in the Argus safety database, including quality review of reports and supporting documents to ensure accuracy and completeness.

●Operates computer automated machinery and related equipment in a continuous production operation to fill and pack drug and prescription orders.

●Performs restocking of automated dispensing systems. Examines quality of product and materials.

●Engage with the site monitors to ensure follow-up information is obtained from site effectively which helps in completing the safety report and make correct causality assessment.

●Processed individual case safety report (ICSR) for clinical and post marketing in Safety Database per standard operating procedure (SOP), Work Instructions (WIN), Adverse Event Reporting plan.

●Perform case management which included receipt, triage, duplicate check, data entry, narrative writing, generating follow up and performing quality review.

●Performed case Prioritization/Triaging based on seriousness of adverse events in accordance with SOP guidelines.

●Coded all adverse event terminology, other medical information, and drug information in safety database utilizing MedDRA and WHO-DD dictionaries, in accordance with coding policies and standards.

●Identified cases that meet SUSAR reporting criteria, prepared the SUSAR narrative, and performed AOSE.

●Processed cases with an accuracy and consistency at various stages of the system workflow.

●Prepared clinical narrative summaries for SAE reports independently from clinical studies and spontaneous post- marketing reports in Argus database.

●Queries related to safety events are reconciled with data management team and resolved timely.

●Performed quality review of individual case safety reports and for providing feedback to team members, working closely with the Case Processing team and Medical Reviewers to ensure complete and accurate information has been entered the safety database.

Pharmacovigilance Associate Jan 2018 – August 2021

Labcorp

Princeton, NJ

●Hands-on expertise in end to end case processing activities (unsolicited, solicited and literature reports) in Pharmacovigilance databases such as Argus, and ARISg.

●Monitoring of drug safety inbox. generating case receipt number, Case Triage, and process adverse event reports according to applicable regulations, guidelines, SOPs, and project requirements.

●Filing PQCs (Product Quality Complaints) associated with adverse events.

●Reviewed and responsible for authoring Standard Operating Procedures (SOPs) and Working Instructions, with minimal supervision. Supported local regulatory and external audits by providing the following activities: Pre-inspection readiness; Inspection activities; Post-inspection activities.

●Assisted drug safety team in triaging of ICSRs to determine their qualification/validity for expedited reporting. Perform quality review for adverse events, serious adverse events(SAEs), and serious unexpected serious adverse reactions(SUSARs).

●Suggested coding CTCAE terms and responded to any pharmacological queries. Performed duplicate searching to maintain consistency with global adverse event database and alerted senior managers to unusual numbers.

●Filing PQCs (Product Quality Complaints) associated with adverse events.

●Ensure data accuracy and consistency.

●Request deletions/admin edit requests, as necessary. Participation in inspection, audits and other ad-hoc requirements as required.

●Utilized therapeutic area of expertise in Oncology to work on behalf of Cancer Therapy Evaluation Program (NCI/NIH). Prepared clinical narratives and independently assigned MedDRA coding to any adverse events.

●Facilitated accurate data entry of Individual Case Safety Reports (ICSR) into adverse event database. Identified clinically significant information from follow-up reports and updated missing information in the initial ICSR.

●Obtained case receipt for adverse event information from LSO and licensing partners to maintain compliance as well as involved in adverse event database upgrades, case management team meetings, and project direction.

●Consistently used ARGUS features such as action items, contact log and work list for communication and for the follow-up requests.

●Worked with medical safety monitor in analysis of safety signals, assessment of potential expectedness, seriousness, causality, drug-related toxicities.

●Responded to regulatory agency inquiries regarding product safety and assisted with FDA inspections within drug safety department.

Education:

●M.Pharma (Pharmacology) JNTU-Hyderabad

●B. Pharm JNTU-Hyderabad

Certifications:

●HIPAA Certified

●ICH GCP Training

●Design and Interpretation of Clinical Trails

●Graduate Certificate in Advanced Drug Safety and Pharmacovigilance

●DIA Pharmacovigilance certificate

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