Himanshu Patel, M.Pharm, Phd Email & Phone Number

Brantford, Ontario, Canada

-Medical evaluations of domestic and foreign ICSRs to assess its reportability to the applicable healthauthority-Performing local and worldwide scientific and medical literature search to identify safety incidents andrelevant ICSRs, and to prepare CIOMS reports for local submission to regulatory agency-Performing CanadaVigilance Adverse Reaction Database screening to identify, evaluate and process adverse events that are directly reported by HCPs and patients to health authority-Attending, evaluating, and answering medical information inquiries from HCPs, patients, and otherstakeholders-Answering medical information inquiries from and providing relevant scientific support to sales and marketing team for specialty pharmaceuticals-Providing scientific support to medical affairs activities in answering regulatory queries and to develop medical education materials for sales and marketing-Reviewing and revising Safety data exchange agreements with foreign partners and implement necessary changes (SOPs, WIs, relevant metrics) for local medical affairs activities-Medical device incident reporting

Ontario, Canada

This was a great opportunity to work for post marketing safety surveillance for COVID-19 vaccine product(s). Some of the important tasks performed were book-in and triage of ICSRs, organizing medical/safety data as per regulatory requirements, MedDRA coding of adverse events, creating safety narratives, and performing assessment of causality, seriousness, severity and expectedness of the reported post marketing adverse events.

Oakville, Ontario, Canada

I had great opportunities to share my expertise as subject matter expert for clinical safety evaluations of adverse events reported during both post marketing survillence and clinical trials, source data quality check and AE reporting in special situations. Training of nurse case managers, newly hired PV associates was another exciting role I had as a part of my work.

Mysuru Area, India

The most enjoyable part of my job was teaching pharmacotherapy to Pharm.D students with innovative methods. Implementation of clinical pharmacy services in oncology practice was the most encouraging, informative and memorable experience for me. Research in oncology pharmacy practice helped us to bring many changes in our clinical practice and ultimately improved cancer care.

Mysuru Area, India

Pharmacotherapy/Clinical Pharmacy teaching, Initiation of clinical pharmacy services in JSS University affiliated Cancer Hospital, clinical trials management at site level and pharmacy practice research were the key features of my job. This job allowed me to do patient care research in several areas like medication errors & its prevention, quality & safe use of medicines, pharmacovigilance, drug use evaluation & policy making. .

Mysuru Area, India

Along with my study, I had a great opportunity to learn and work for Phase III clinical trials in area of Diabetes and Neurology. This was wonderful experience in terms of learning all clinical trial activities, ethics committee communication, adverse event reporting and investigational drug management.

Research Scholar, Oncology Pharmacy

Doctor Of Philosophy - Phd, Oncology Pharmacy

Master Of Pharmacy (M.Pharm), Clinical Pharmacy Practice, First Class With Distinction

Bachelor Of Pharmacy - Bpharm, Pharmacy, First

Pharmacy