Mohammed M. Chowdhury, MD

Boston, MA 302-***-**** adtskh@r.postjobfree.com

Summary

Versatile, resourceful, and results-driven physician to lead and support functions that involve ICSR processing, medical review, and compliance activities. Excellent experience in case processing, adverse event reporting with keen medical insight for safety and efficacy of products. Good knowledge of US and EU Pharmacovigilance regulatory requirements. Hands-on expertise in start to end of case processing in Pharmacovigilance databases such as ARGUS, and ARISg.

Professional Experience

Clinical Safety Associate, Merck, Rahway, NJ. April, 2020 – Present

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.

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

Determined 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, in accordance with coding policies & 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.

Process safety data according to applicable regulations, guidelines, standard operating procedures (SOPs) and project requirements.

To perform pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming adverse events.

Coding AE and products, writing narratives, literature related activities, quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/project timelines. Creating, maintaining and tracking cases as applicable to the project plan.

Assess safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedite reporting.

Liaise with manager for regulatory tracking requirements and electronic reporting.

PV Safety Associate III, Amneal Pharmaceuticals, Bridgewater, NJ. Jan, 2017 – Mar, 2020

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.

Assisted with FDA inspections within drug safety department.

Education

Widener University, Chester, PA - Pre-med Biology

Universidad Iberoamericana, Santo Domingo, RD - Bachelor of Science, Health Science

Washington University of Health and Sciences, Belize - Doctor of Medicine

Publication

Langberg, K.M., Solad, Y., Ciarleglio, M. Sukumar, N., Teslya, P., Chowdhury, M.M., Aslanian, H. R., Primary Care Physicians Could Play a Role in Improving Colonoscopy Quality Measures. Dig Dis Sci 62, 1383–1384 (2017).

https://doi.org/10.1007/s10620-017-4551-9

Skills

Adhere to and Implement SOPs

AEs/SAEs reports, spontaneous, regulatory authority, literature and clinical trial case reports

Understanding of ICH-GCP, HIPAA guidelines and GVP Module VI Guidelines

Knowledge in expedited and periodic reporting timeline requirements set by regulatory agencies

Experienced in Safety Reporting and Regulatory Compliance

Ability to work in cross functional teams

Demonstrate strong scientific writing skills

Coaching and mentoring

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