Rizwana Aftab

**** ****** ****

North Brunswick, NJ 08902

Phone: 732-***-**** EMAIL: ad15w5@r.postjobfree.com

SUMMARY:

Medical and Drug Safety professional with 5 years of experience in adverse event reporting and case processing. Skilled at using Oracle Argus Safety 8.0, coding cases using MedDRA 22.1 and WHO drug coding. Proficient in performing causality assessment, writing case summaries and assisting in preparing reports for FDA, EMA and EU submissions. High-energy result-driven dedicated, team player, multi-tasking experienced professional with strong communications and problem-solving skills. Seeking a full-time Drug Safety/PV position, focusing on case processing.

SKILLS:

PROFESSIONAL SKILLS:

Experienced in Oracle Argus Drug Safety database (Version 8.0) and MedDRA (Version 22.1)

Understanding of ICH-GCP and HIPAA guidelines and GVP Guidelines.

Experienced in Corrective and Preventative Action (CAPA) in analytical roles.

Knowledge of 21 Code of Federal Regulation parts 11, 50, 54, 56, 312, 314

Capable of Serious Adverse Event (SAE) reporting and Individual Case Safety Reporting (ICSR).

Hands on experience to submit SAEs and SUSARs to concerned authorities like FDA within designated timelines.

Excellent knowledge of medical terminology.

Proficient in Narrative Writing, Medical Review.

Hands on experience in Causality, Expectedness and Seriousness Assessment.

Understanding of Signal Detection and REMS.

Preparation of PADERS, PBERS, AGGREGATE REPORTS for inspection and reporting to concerned RA. like FDA, EMA.

Experience of Medical Narrative writing with full evaluation of Data Core Sheet, IB and PI, and Causality Assessment using Algorithms, De-challenge, Re-challenge and Medical judgement applying medical knowledge.

PERSONAL SKILLS:

High-energy driven dedicated professional

Team player

Multi-tasking skills

Strong communication, verbal and writing skills

Problem-solving skills

Attention to details

Analytical skills

Stress resistance ability

Highly organized

Presentation skills

Time management skills

Interacts perfectly with cross functional teams.

Ability to work in fast paced, time-oriented environment.

COMPUTER AND

TECHNICAL SKILLS:

MS Word

MS Excel

MS Power Point Presentation

Oracle Argus

Blackboard

Canvas

Dealing with new media

Eager to learn new technologies to improve job skills.

Quick learner and ability to adopt and modify to work equally best in new environment.

Proficient in MedDRA and WHO coding.

Adobe Acrobat Distiller and Pro XI

PROFESSIONAL EXPERIENCE:

(15 Jul 2022-

14 Apr2023) BMS

CLINICAL SCIENTIST

Review clinical data, SAEs coding, lab data, narrative, causality for accuracy and quality assurance as medical monitor of the studies.

Review of CERs to assess clinical evidence. clinical data, adverse events, causality and monitoring follow ups.

Lead meetings with multifunctional groups, Signal detection, Epidemiology and Stats teams.

Working on Veeva, Rave, Registry tools for accuracy of important medical data.

Working in coordination with Regulatory and Project Management and Statistical teams to evaluate product’s risk

benefit ratio.

Provide scientific clinical leadership in conducting extensive data review in RAVE under minimal guidance and oversight from his/her supervisor

Review and query of hematology data including but not limited to: eligibility criteria, primary efficacy variables, pathology, anti-myeloma therapies, and laboratory data.

Coordinate with contract research organization (CRO) and liaise with clinical sites for timely data completion.

Assist the Clinical Research Scientist team to interface with project team members including: Clinical Research Physician, Clinical Operations, Study Manager, Data Management, Statistics, Safety, Regulatory and Project Management.

Support with clinical study report preparation.

Participate in ad-hoc meetings.

Support clinical trial activities as requested.

Provide scientific leadership and guidance for established protocols, and all applicable SOPs.

Provide input to respective teams for clinical trial design, basic statistics, and data review tools.

Have expertise in MedDRA, WHO drug dictionary, TMF, J Review, Veeva, Infosario and RAVE.

Excellent knowledge of medical terminology.

Review of ICF, Protocols, Protocol Amendments.

Review of listings for adverse events, clinical evaluation of CRFs.

(10 Jan 2022- JOHNSON &JOHNSON

5 May 2022) SENIOR DRUG SAFETY SPECIALIST

Working on Vaccine clinical trials and post marketing cases.

Performing all activities included which come under PV including case processing, analyzing and entering data, assessment of case, comprehensive narrative writing.

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

Ensure a duplicate check using Global Safety Database (ARISG) for all ICSR (Individual Case Safety reports) for existing case file.

Assessment of Case Reports for Seriousness, Causality and Expectedness for risk manaent and safety profile of products.

Medical assessment of causality, dechallange, rechallenge and performing labelling assessment as per related protocols, Write comprehensive medical narrative of CSR with scientific information, details of related investigations and related medical information.

Prioritizing the adverse event reports (SAEs, SUSARs) processing base on the ICH dates.

Perform Medical Review of cases when needed with Causality Assessment per WHO Guidelines and Narrative check of the case.

Coding of medical history, drugs and reported adverse event terms in safety database using medical dictionaries like MedDRA and WHO.

Setting up follow-up. Produce Clinical Safety Queries as needed for clarification of reports.

Case clean-up activities, as necessary, including case maintaining inspection readiness.

Implemented/Maintenance/Upgrade the medical coding process used in department and respective medical coding dictionaries MedDRA and WHO DRUG.

Experience using a drug safety database to capture adverse events.

Proficiently doing Causality assessment, dechallenge, rechallenge using WHO guidelines and expectedness assessment using USPIs, IBs, (related protocols).

Experience applying medical knowledge in a business context.

Experience working in a post-marketing safety and clinical trial cases and vaccine cases.

(22 Jul 2021 Parexel International

20 Dec) Drug Safety Specialist

Performing all activities included which come under PV including case processing, analyzing and entering data, assessment of case, comprehensive narrative writing.

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

Worked on Respiratory disease products Zambon, Oncology products Fotivda, to assess safety profile, protocols, IBs, etc.

Ensure a duplicate check using Global Safety Database (ARGUS) for all ICSR (Individual Case Safety reports) for existing case file.

Perform Case book in and Data Entry.

Assessment of Case Reports for Seriousness, Causality and Expectedness.

Prioritizing the adverse event reports (SAEs, SUSARs) processing base on the ICH dates.

Perform Safety Data entry in the database, Coding relevant Medical Terminology, Writing Narratives for MedWatch (FDA 3500A) and CIOMS forms for domestic and international cases, Generating queries pertinent to the case.

Experience using a drug safety database to capture adverse events.

Experience applying medical knowledge in a business context.

Experience working in a post-marketing safety and clinical trial cases.

Proficiently using Veeva Vault and PMED.

(20 Sep.2020-

19 Jul 2021) Aris Global, NJ

Drug Safety Documentation Specialist

Working on BMS Project to document and modify all processes as per E2B Guidelines for ICSRs from Aris G and LSMV (LSMV is Life Sphere Multi Vigilance, latest and most advanced software tool to enter adverse events and data from received sources to prepare ICSRs and for reporting of ICSRs to Regulatory Authorities).

Lead meetings with BA maps and chart flows and set up deadlines for projects and follow up with teams for assurance of providing high quality work within recommended timelines.

Working on LSMV and Aris G for ICSR data entry.

Document and map the workflow of all safety information to facilitate routing, review, approval, and timely case finalization, submission and archiving with hands on experience of Aris G and LSMV.

Document WIs, SOPs, Forms, Manuals, IBs, Protocols as per E2B Guidelines for PV, Adverse events, ICSRs and Aggregate reporting.

Document ICSR adverse events, Medical Review, Quality Review activities in all respective fields of LSMV.

Proficient in using Aris G Coding Manual, proficient in MedDRA Coding and complete understanding of Company Core Data sheet, PI, and/or IB for accurate labeling and listedness.

Proficient in writing comprehensive Narratives with all important medical information.

Perform QA Activities for ICSRs, CAPAs, Root Cause Analysis.

(Apr.2020 – J&J, Somerville, NJ

15 Sep.2020) ICQA Coordinator

As ICQA Coordinator maintain Agreement Documents of Medical Devices (EUMDR), among different business entities and ensuring compliance and submission to FDA and EU MDR Regulations, 21 CFR Part 820.

Lead Cross functional meetings using tools like skype, web ex, zoom.

Manage the workflow of all safety information received into the department to facilitate routing, review, approval, and timely case finalization, submission and archiving of MDRs.

Enter data and process documentation of receipt of safety reports, follow-up information, and source documents.

Send team notifications of receipt of safety information in accordance with Safety Management Plan timelines and Data entry of basic fields into Drug Safety Database. Preliminary coding of all adverse event terms and Assess reports for follow-up reporting requirements

Maintain and update Records in tool ADAPTIV.

Participate in CAPA, RCA, KPIs and maintain compliance and updates in ETQ. Lead CAPA Activities and make sure of their implementations.

Maintain Product complaint adverse event records and Agreement Documents in ADAPTIV.

Participate in Audits and Inspections.

Plan, edit and maintain and update SOPs, Job Aids, Quality Manuals per applicable modified global standards and regulations, maintain CAPA in "ETQ".

Promotional Medical Device review and update of Scientific documents as per global promotional materials and medical information.

(Feb.2020 - Sollers, Edison, NJ

-June 2020) Aggregate Reporter, (Part time Internship)

As Aggregate Reporter and Medical Reviewer I performed following functions:

Extraction of NDA line listing from Argus Safety for preparation of PADERs.

Overview of PADERs and its preparation

Extraction of ICH line listing from Argus Safety for preparation of PSURs

Overview of PSURs and its preparation

Literature Search and identification of Potential and Identified Risk

Extraction of Case listing for Aggregate reporting purposes

Summarize tabulation of ADR cases in Oracle Argus Safety Database like Argus

Preparation of Content and preparation of the reports

Following Country specific requirements

Following Guidelines governing periodic reports

Compile the safety data into the relevant sections of periodic reports such as PBRER, PADER, and DSUR according to the client.

Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal detection.

Create all documents in accordance to all applicable SOPs, and convention of the client.

Plan, organize, and manage daily work to meet service level timelines and deliverables.

Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work.

Provide word and PDF versions of the final signed documents to the client.

Participate in internal and external audits and inspections by clients and health authorities.

Analyze and interpret aggregate patient safety data relating to drug products

Ability to work independently but guided by documented procedures, with appropriate support.

Ability to interpret and follow the patient safety guidelines of the FDA and comparable international regulatory organizations such as the International Conference on Harmonization.

Experience and report writing skills in accordance with agency requirements for content, format and timelines.

Able to work effectively as part of a team. Lead meetings with Cross functional teams.

Understanding of patient safety regulatory obligations and well familiar of regulatory &Pharmacovigilance guidelines and familiar with Pharmacovigilance and medical terminology.

Excellent attention to detail and ability to deliver within established timelines.

Leads and collaborates with Aggregate Reports on strategy, review, and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).

(Nov '19 to Sanofi-Aventis, Bridgewater, NJ

March’20) QA Associate II

Ensuring compliance of all PV Activities with GVP, regulations and established procedures.

Support review of PV Data (ICSRs, PSRs,etc.) in AEGIS and utilizing TASQ for reviewing, reporting and updating Case findings as per AUM guidance and assigning Criticality to each finding.

Utilizing Quality Assurance Database TASQ and reviewing documentation for compliance with GVP, FDA, ICH, and other regulatory requirements and performing administrative tasks.

Utilizing AI in initial stages, getting trained for high level performance.

Arranging and leading meetings to review QA process with colleagues to evaluate KPIs, RCAs, and preparation of CAPAs and making sure of their approval, implementation, effectiveness.

Making sure of all tabs of AEGIS ICSRs including Narrative writing are E2B Compliant.

Applying deviation process (If the data points are away from the mean or normal, that is deviation), during QA investigation for deviations categorize deviation and find out RCAs and implement CAPAs depending on their severity.

Supports Safety Management Team (SMT), Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, and meeting minutes review, slide preparations.

Obtain data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician in determining the impact of the safety issue on the products benefit/risk profile.

Participates in ongoing SAE reconciliation between the safety and clinical databases.

Review Medical writing for SUSARs, ICSRs and provide feedback on medical coding, treatment and outcome, to update within timelines. And assigning Criticality, Root cause analysis and KPIs to findings.

Arrange and lead Cross functional team meetings for Medical Review of Medical Documents and ICSRs.

(Sep’18 to May’2019) Sollers, Edison, NJ

Drug Safety Associate (Internship)

Performed all activities included which come under PV including case processing, analyzing and entering data, assessment of case, analysis of reports for Signal Detection, REMs, CAPA.

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

Experience applying medical knowledge in a business context.

Experience working in a post-marketing safety and clinical trial cases.

Utilizes medical, scientific and clinical knowledge in reviewing safety-related documents (e.g. protocols, investigator brochures, product labels, relevant source documents) and incorporating key concepts to clearly present the reported events, and in turn, maintain patient safety.

Proficient in writing medical narrative as a brief, concise, structured but clear summary of specific events with logical flow of information experienced by patients, for clinical trials and post marketing AE cases involving multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required. Conclude causal relationship between the investigational drug and AE, using UMC terms certain, probable/likely, possible, unlikely, conditional and un assessable, also using Naranjo Questionnaire to determine likelihood of whether ADR is due to the drug after having scores for terms like definite, probable, possible, doubtful. In addition, also include patient identifier, age, sex, race (height and weight, if relevant), disease being treated (if relevant), prior and concomitant medications, medical history, and active/ongoing medical conditions, case assigned number.

As a Medical Dr. Have in-depth knowledge of the therapeutic areas and hence verifies medical plausibility of the event/s, inclusion/exclusion of the content from a scientific perspective, safety data reported in the narrative, and flow and alignment of contents according to the applicable regulatory requirements.

Provide comprehensive medical review report effectively, for that report to be used in Regulatory norms, challenges, signal detection, risk and mitigation strategies.

Provide Medical Narrative using succinct style and presentation and provide a medical and scientific context in terms of the event(s) for which it is being written. Providing logical flow in Medical writing to describe event(s) in a patient narrative with following order:

Clinical course of the events, with an indication of timing of event corresponding to study drug administration.

Nature, intensity/severity, and outcome of the event

Relevant laboratory findings

Treatment administered for the event

Action taken with respect to the study drug

Postmortem findings (if applicable)

Investigator's and sponsor's assessment (if required) on causality.

Conduct the assessment of all serious individual adverse event case reports stemming from preclinical studies, post marketed and literature cases.

Performs quality control of key data fields, and makes updates in the safety database per process Conventions

Executes case assessment (review events, determine expectedness, review/update drug and medical term coding, determine causality)

Creates clear, medically concise case narrative procured from relevant information in form of various source documents

Experience working in teams, including supporting other team members when necessary.

Strong teamwork (with ability to lead a team) and prioritization skills to ensure that processes, procedures and best practices are consistent across GPV&FDA and that Regulatory requirements are met in timely manner with high quality.

(2014-2021) TEACHING AT KEAN UNIVERSITY AND COLLEGES

Teaching health science courses including Anatomy and Physiology I & II, Nutrition, Practical Nutrition, Human Biology and General Biology.

Developing and implementing daily and unit lesson plans for class and laboratory.

Administering tests and evaluations, and analyzing student performance using Blackboard.

Managing and supervising A&P laboratory.

Responsibilities include academic advising of students, participation in school committees and activities, and supervision of projects.

(June ‘98 to June ‘99) Civil Hospital, Karachi, Pakistan

Oncology Department, Patient Dose Calculator and Adverse event Reporter

Collected adverse drug reaction report, analyzed, validated, evaluated causality, document and report to the pharmaceutical company that holds the marketing authorization for such drug.

(July '96 to May ‘98) Rab Hospital, Karachi, Pakistan

Patient and Drug Safety Supervisor

Collected adverse drug reaction report, analyzed, validated, evaluated causality, document and report to the pharmaceutical company that holds the marketing authorization for such drug or to the regulatory body as required. Conduct follow up for reported cases with incomplete information to validate the reported adverse event. Worked in GI Department and Gastro AEs.

(June '95 to June ‘96) Civil Hospital, Karachi, Pakistan

Residency in Medicine and Surgery

Provided care to medical and surgical patients on hospital wards, outpatient clinics. Prescribe medicines to patients and giving them instructions on how to use them. Conducting and following up patient’s medical records for any further testing and diagnosis on a regular basis. Coordinating with patients regarding their concerns.

OTHER

EDUCATION: Bachelor of Medicine, Bachelor of Surgery (MBBS) – M.D. equivalent,

Dow Medical College, Karachi, Pakistan (1990-1995)

WORK STATUS: US Citizen (Authorized to work for any US employer)

REFERENCES: Available upon request

LinkedIn: http://www.linkedin.com/in/rizwana-aftab-3082451b1

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