Clinical Trial Medical Review
Resume:
Mihir Patel
Lawrenceville NJ ****8
**********@****.***
Skills
Experienced in evaluating risk associated with by being involved in various activities of safety surveillance including medical evaluation of individual case safety reports, signal detection, risk evaluation and mitigation strategy (REMS), and aggregate safety reporting and analysis. Experience
JANUARY 2021 - PRESENT
Amneal Pharmaceuticals, Brookhaven, NY - Pharmacovigilance Scientist
● Oversee signal detection/safety monitoring activity for all post marketed products.
● Provide medical input and review of aggregate reports (PADER, PBRER, DSUR), safety sections of relevant clinical trial documents (e.g., protocols, clinical study reports, investigator brochures)
● Medical review and approval of all signal reports as per the regulatory requirements.
● Support to prepare and review answers to safety queries from regulatory authorities as needed
● Oversight of ICSR function which includes intake, processing, review, and submission of all ICSRs in ARGUS database..
● Represent PV in clinical development projects providing expert medical guidance on safety matters for investigational products.
● Support preparation of Health Hazard Assessment (HHA) Reports
● Support development, maintenance, and execution of Safety Data Exchange Agreements
(SDEA) with business partners and distributors.
● Evaluation of serious clinical trial adverse events (SAE and SUSAR) for a trial to evaluate the safety and efficacy of IPX203 (Extended-release Carbidopa-Levodopa) in Parkinson’s Disease Patients with Motor Fluctuations.
● Medical evaluation of individual case safety reports (ICSRs) including seriousness assessment, causality assessment, narrative review, and review of source documentation for accuracy and completeness and authoring company comment.
● Assess, medical review and electronic submission of expedited ICSRs through ARGUS database. .
● Actively participated in implementation of internal processes for medical review and regulatory submission of Combination Products including transdermal and auto-injectors as per USFDA regulatory requirements.
● Supervising and guiding Drug safety vendor/ CRO. 2
● Conduct medical literature review for all Amneal products for special projects. Perform oversight of PV vendors for Literature monitor.
● Supports development, implementation, and maintenance of SOPs related to pharmacovigilance activities.
● Training new hire employees with respect to Pharmacovigilance processes. JUNE 2018 - JANUARY 2021
Northeast Urologic Surgery - Andover, MA - Medical Secretary/Receptionist
● Registered and scheduled patient appointments for five physicians
● Collected patients' payments, posted the daily charges, and prepared daily deposits
● Handled inbound faxes from pharmacies, insurance companies, test results, and consultation requests
● Retrieved and scanned all patient medical information
● Gathered and recorded all patient information including health insurance eligibility, referring physician, past medical information, and test results APRIL 2014 - JULY 2018
Lake Region Healthcare – Fergus Falls MN - Medical assistant
● Acted as a Medical assistant in all the departments; Lab, Autoclaving, Family medicine, Walk-in-clinic, EKG dept., Registration and BP clinic. JANUARY 2014 - APRIL 2014
Sanford Hospital - Bismarck ND - Shift team leader
● Served as liaison for the environmental services department of hospital
● Functioned in the position of department member for the QA Team of the hospital
● Co-ordinated cleaning of clean rooms according to federal and state regulations Education
APRIL 2014 - JULY 2015
Rasmussen College, Fargo-Moorhead ND - Diploma of Applied Science - Medical Assisting
OCTOBER 2002 - NOVEMBER 2008
University of Medicine and Pharmacy “Victor Babes” Timisoara, ROMANIA - MBBS
(Bachelor of medicine and Bachelor of Surgery)
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