Hitesh S. Patel

.Pharmacovigilance Medical Reviewer

US Citizen

551-***-**** adrsfx@r.postjobfree.com

Belle Mead, NJ 08502

Analytical and detail-oriented drug safety professional with experience ensuring drug safety in the pharmaceutical industry. Proven track record coordinating adverse events programs, following up on case reports, offering information on product safety to healthcare experts, and updating knowledge of pharmacovigilance. Known for knowledge of clinical trial processes, a meticulous approach to work, integrity, analytical thinking, decision making, and time management. Driven by sense of urgency, ownership, and personal accountability committed to personal and professional growth.

AREAS OF EXPERTISE

Pharmaceutical Industry Drug Safety Guidelines Periodic Safety Reports (PSUR) MedDRA

Serious Adverse Events (SAE's) Individual Case Safety Report (ICSR) CFR ICH GCP

Quality Review of ICSR PADERS WHO-DD ARGUS EUA VACCINE EUA MONOCLONAL ANTIBODIES EUA VACCINE

EXPERIENCE

ProQuest, Ann Arbor, Michigan July 2021 – July 2022

Pharmacovigilance Literature-Medical Review assessment

Advised Operation team members on any clinical questions regarding adverse events.

Created monthly reports for multiple clients.

Tracked operational metrics, provided client service support, performed standard quality assurance reviews on cases prepared by other case managers, identified key training and development opportunities/needs, helped develop working practices (WP) and train new staff.

Abstracting and indexing of abstract and articles, including medical review of articles for products

IQVIA, Durham, NC March 2021 - October 2021

EUA Vaccine Medical Reviewer / Operational Specialist 2

Process Safety data according to applicable regulation, guidelines, Standard Operating procedures (SOPs) and project requirements.

Ensure to meet quality, productivity and delivery standards according to project requirements.

Self-Quality Review of expedited and non-expedited cases.

Promote an enriching, collaborative, and positive team environment.

Maintain top metric performance for case quality and top 5% number of cases completed per month within a large team.

Assist train new associates on team.

Sub-group lead within a larger team group.

Medical Review of ICSR during high volume periods.

PrimeVigilance USA Inc, Cary, NC (previous name: Ashfield Pharmacovigilance) Jul 2020 – Feb 2021

PV Physician

Provided medical review of clinical and post-marketing safety reports. Assessed clinical significance of adverse events and their ramification for product use.

Performed medical assessment of and evaluation of databased adverse event cases in reference to expectedness, causality, medical coding of adverse events with the MedDRA dictionary and product coding using the WHO dictionary.

Medically review PADERS; Line Listing including providing clinical signification statements.

Perform medical review for SUSARs.

Communicate with client Medical Reviewer regarding ICSRs.

Worked with products concerning the current Covid-19 Pandemic and other therapeutics.

Hitesh S. Patel, MD adrsfx@r.postjobfree.com Page Two

Ashfield Pharmacovigilance, Cary, NC March 2019 – July 2020

Literature Team

Literature Lead who maintained client literature medical assessment reviews, reviewed abstracts, and articles. Sent adverse events found within citations to operations team.

Advised Operation team members on any clinical questions regarding adverse events.

Created monthly reports for multiple clients.

Performed ad hoc authoring of clinical significance reviews for PADER reports.

Tracked operational metrics, provided client service support, performed standard quality assurance reviews on cases prepared by other case managers, identified key training and development opportunities/needs, helped develop working practices (WP) and mentored/trained new staff.

Ashfield Pharmacovigilance, Cary, NC August 2017 – March 2019

Case Manager II, Oncology Team

Ensured timely and accurate data entry, recording, peer reviewing and analysis of non-serious and serious adverse events (SAEs) of Individual Case Safety Reports (ICSRs) and special scenario cases.

Focused on preparing, editing, correcting, and reviewing safety reports.

Performed post-market surveillance activities by literature reviews (e.g., extracts data from literature and prepares summaries into case reports) for drugs and medical devices.

Worked on product quality complaints and recorded manufacturing procedures needed for quality assurance.

Worked on Argus safety database to manage case workflow, case triage, duplicate cases, accurate data entry, coding drugs and events details, determining seriousness of events, medical narrative writing and generated follow-ups to manufacturers or consumers.

Possessed good knowledge of regulatory requirements and first-rate understanding of regulatory submissions and timelines.

Correct decision making ability based on case seriousness to clearly identify and triage cases that are time sensitive and require high priority processing to prompt reporting of Serious Adverse Events (SAEs) in accordance with company SOPs, FDA, ICH and worldwide post marketing and clinical trial regulations.

Performed SAE reconciliation between clinical and safety database

Processed safety reports of various types: company sponsored clinical trials, post-marketing observational studies and non-clinical spontaneous reports.

Identified quality requirements by reviewing regulations and Standard Operating Procedures (SOPs) and following up on improvement plans or process changes.

Evaluated and ensured that accurate and complete relevant scientific and medical information had been entered into the safety database by contacting healthcare professionals or consumers and confirming information.

Generated CIOMS, determined if appropriate case follow-up had been considered and conducted follow-up activities when needed.

Authored medical narratives and performed scientific coding of drugs and events using WHO and MedDRA dictionaries.

Utilized a great knowledge of study protocols, informed consent, Case Report Forms (CRFs) and medical writing.

Ashfield Pharmacovigilance, Ivyland, PA and Fort Washington, PA February 2017 – March 2017

Case Manager II

Orchestrated triaging, entry, and case finalization including regulatory submissions for complex cases requiring subject matter expertise.

Provided quality customer service including robust communication and prompt follow-up to client queries. Performed a range of operational support activities including audit preparation, quality review, training, and mentorship.

Tracked operational metrics.

Hitesh S. Patel, MD adrsfx@r.postjobfree.com Page Three

EDUCATION

Doctor of Medicine (MD)

Spartan Health Sciences University School of Medicine, Vieux Fort, St Lucia, West Indies

Pre-medicine

Emory University, Atlanta, Georgia

PROFESSIONAL DEVELOPMENT

Four Years of Clinical experience which also included over two years of clinical experience performed in Atlanta, Georgia, and Chicago, Illinois, USA with documented performance.

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