Pharmacovigilance, drug safety, ICSR, MEdra

SAURABH HANDA

+1-437-***-**** **.************@*****.*** LinkedIn

PROFILE

Healthcare professional with 8 years of diverse experience in dentistry and in collection, intake, processing, quality check and reporting of Safety events (Adverse Events and/or Product Complaints). Looking for suitable opportunity to explore and help to invent the best business processes in compliance with Global PV Regulations and related ICH guidelines. Innovative, Versatile, promoting an atmosphere of teamwork, ensuring excellent customer service and strong decision making and problem solving skills. Hard working professional with excellent attention to detail and excellent written, verbal communication and facilitation skills with effective decision making and timely delivery of quality drug safety data. CORE COMPETENCIES

ICSRs (case processing including Intake, Triage, Data Entry, Narrative Writing, generating follow- up questions, Data Validation, Quality Control and Submission).

Reviewing pharmacovigilance reports received for accuracy and validity.

High level knowledge of handling Safety Databases ( Oracle ARGUS) and MedDRA terminology.

Knowledge of ICH (International Conference on Harmonization), GDP (Good Documentation Practices), GCP (Good Clinical Practice), Health Canada GVP (Good Pharmacovigilance Practices), Health Canada Adverse Event Reporting guidelines and familiarity with Canada Vigilance-MedEffect Program.

Conducting QC (quality check) of journal notes/PIRs/RSN calls/Lab reports/ PV reports and other applicable documents for potentially missed reporting of safety events.

Proficient with Microsoft Office Suite (Outlook, Word, Excel) KEY SKILLS

Strong knowledge of various disease states, internal medicine, physiology, toxicology and pharmacology.

Experienced in handling highly complex ICSRs, PSURs and RMPs.

Excellent organizational & critical thinking skills.

Languages known: English, Hindi, Punjabi (both written and spoken, complete professional working proficiency). French (enrolled in French language course).

Team Player with ability to function in a multi-disciplinary environment and promote collaboration. PROFESSIONAL EXPERIENCE

SHOPPERS DRUG MART- CANADA

Pharmacy Assistant (November 2019- Present)

Operated and maintained the Synmed® Automated Dispensing equipment used to generate and produce weekly compliance packs for SDM stores.

Ensured that the Synmed® machines have the correct and necessary supply of medication within the dispensing unit to prepare the compliance packs.

Checked the quality of the medications dispensed from the machine.

Prepared and packed the medications while ensuring the number of pills in each packet were correct.

Worked in a fast-paced environment where high attention to detail and accuracy was essential. PAREXEL INTERNATIONAL SERVICES

Drug Safety Analyst (November 2017-September 2019)

Monitored the compliance on compliance investigation tool by monitoring the standardized ICSR lateness reasons.

Participated in program specific PV audits and ensured compliance with Adverse Event reporting guidelines and Good Pharmacovigilance practices.

Ensured timely submission of initial and follow-up PV reports as per the program requirements and/or PV agreement.

Performed reconciliation of reports with applicable departments to ensure all the incoming cases were processed as per the conventions and to confirm potential AEs as a result of quality related complaints.

Drug Safety Scientist (December-2015-October-2017)

Captured and assessed single adverse events reports associated with customer’s products on a worldwide basis on the drug safety database, in accordance with international and local regularity requirements. Preliminary data entry in the Electronic Case Registration (ECR) system.

Managed workflow; identify and escalate issues

Performed Quality Control (QC) of cases for the accuracy of data captured on Client’s database per relevant guidelines and procedures

Handa Dental Clinic & Implant Center (March 2013 – December 2015)

Lead practitioner: Responsibilities include providing direct patient care including physical examinations, diagnosing the dental condition and providing the required treatment. Sharma Dental Clinic (April 2012 – February 2013)

Guiding team of doctors to provide treatment to incoming patients. Christian Medical College Ludhiana (October 2011 – March 2012)

Earned Practical knowledge of latest discoveries in dental field and handling of patients. KEY ACCOMPLISHMENTS

Trained, coordinated and monitored the activities of the internees which helped the compliance monitoring project to streamline.

Built excellent rapport with the internal and external Pharmacovigilance team.

Demonstrated initiative and accountability and be able to work under minimal supervision.

Worked with strict timelines and handled multiple priorities. EDUCATION

Bachelor of dental surgery from Surendera Dental College & Research Institute, Sri Ganganagar, India

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