Ashish Karade Email & Phone Number

India

perform Medical Review activities for different Projects

Maharashtra, India

- Maintained near 100% submission compliance for case processing (ICSRs) and benefit risk assessment reports (including signal management, risk management and aggregate safety reports) and systems to capture global medical information activities for products.- Authored and reviewed signal assessment reports which included eRMR listing, no new signals were.

Hyderabad Area, India

- Monitoring clinical safety of projects/ products including activities such as literature review, evaluation of individual cases, signal detection, and respond to safety-related questions, appropriately. Performed medical assessment for single cases, as required, including collecting additional follow-up information, medical evaluation of product quality.

Kurla, Mumbai

- Implemented Pharmacovigilance System for the newly formed department by understanding the global requirements and authoring the required processes for ICSR, PSURs / PBRERs, PADERs, RMPs, Signal management, PSMF, pharmacovigilance agreements and literature review for Human and Veterinary use products.- Raised the compliance to above 95% for the regulatory.

Mumbai, Maharashtra, India

- Prepared end-to-end product aggregate reports (PBRER/ PSUR, DSUR, QSUR, PSR, Safety Assessment Reports and Safety Progress Reports for South Africa) starting from conducting kick off meetings, requesting information from stakeholders, authoring the document, authoring the medical safety section, coordinated for any delays in information or any issues.

Mumbai Area, India

- Attended the kick-off meeting, assessed the safety sections of product aggregate report (PSUR, AR), presented literatures with medical assessment, improvised individual narratives for medical correctness and provided, in coordination with the Client Safety Physician, conclusion for safety of the product. Coordinated with the submission team for smooth.

Mumbai, Maharashtra, India

- Performed medical review of clinical trial, spontaneous, legal case reports, post-marketing surveillance and literature reports, and ensured timely regulatory submission of ICSRs.- Medical review included providing medical comment for causality; and assessing MedDRA coding of events and medical history, product coding, labeling assessment, patient.

MIDC, Opposite Seepz Gate no. 1, Andheri East

- Handled BA BE studies as an in-charge of the study. Reviewed informed consent form. Presented and coordinated ICF related activities to volunteers.- Conducted medical examination of volunteers for screening, evaluated their laboratory/ Safety reports.- Supervised drug administration activity as per protocol. Handled, managed and recorded Adverse Event.

Rural Hospital, Palandur

Operational:- Performed clinical management including minor surgeries of in- and out-patients with referrals to Tertiary care institution, as necessary.- Managed pregnancies; from routine check-up till delivery with referrals, as applicable.- Handled medico-legal cases, issued medico-legal certificates and attended as expert witness in the courts.- Planned.

Primary Health Center, Bhuyar

Operational:- Performed clinical management including minor surgeries of in- and out-patients with referrals to Tertiary care institution, as necessary.- Managed pregnancies; from routine check-up till delivery with referrals, as applicable.- Handled medico-legal cases, issued medico-legal certificates and attended as expert witness in the courts.- Planned.

Associate Fellowship Industrial Health, Occupational Health And Industrial Hygiene

Sion, Mumbai in May 2011.

Apgdcrm, Clinical Research

Advance Post graduate diploma in clinical research and management

Bachelor Of Medicine, Bachelor Of Surgery (M.B.B.S.), Medicine

Activities and Societies: Volunteered for International conference of PharmacologyMaharashtra University of Health Sciences, Nashik in.

Education record

I was in 11th and 12th standard (HSSC 10+2)

Education record