Data Entry Follow-Up

Piyush Rawat

******.*******@*****.*** linkedin.com/in/piyush-rawat-751a6449/ +1-647-***-****

Career Summary

A foreign registered Pharmacist with a master’s degree in pharmacy with more than 10 years of diversified experience in information management of Individual Case Safety Reports (ICSRs) of all case types

(spontaneous, clinical studies, solicited programs and literature articles) which include triage, registration, duplicate search, data entry, MedDra coding, causality assessment and data validation of ICSRs. Experience in preparation of aggregate periodic safety data reports including Periodic Benefit Risk Evaluation Reports (PBRERs) and Semi-Annual Safety Reports (SASRs). Professional Experience

Manager, Pharmacovigilance, AmerisourceBergen Corp (Innomar strategies), Canada Nov 2021 to Present

Leading team meetings as required: presenting data, process changes or updates to the team and addressing any concerns or questions.

Managing issue-review and CAPA activities (initiating issue-review, follow-up on corrective and preventative actions, and submission of issue-review to client).

Ensuring audit-readiness of assigned programs (ensuring processes are accurately reflected in WI/SOPs, maintaining organization documents, maintaining communication records, and maintaining up-to-date internal trackers).

Managing personnel (performance of direct reports, coaching and mentoring, as well as hiring activities).

Assist with the periodic review of PV governing documents such as SOPs, Policies, and Work Instructions.

Ensure PV processes follow all ICH-GCP guidelines, current global regulations, and contractual agreements with our clients.

Senior drug safety associate (Project lead), AmerisourceBergen Corp, Canada Dec 2019 to Oct 2021

Local safety officer (Canada) for a major client handling regulatory reviews for assigned products as well as drafting of changes made to product monograph (if any)

Providing leadership and structure for customer service from scoping stage, through proposal generation, bid defense to transition of work and service delivery, throughout the development and commercial lifecycle of the product.

Preparing AmerisourceBergen project scope Corp and objectives based on the signed agreement between the client and.

Acting as the primary contact point for project-related matters

Review the Health Canada database for adverse events reported for client products.

Submitting adverse event reports to clients, ensuring completeness and accuracy of the report

Work with patient assistance program managers in event of audit and assist client with health Canada audits.

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

Coordinating with client and program to complete monthly QC activities for the programs within client requested timelines.

Provide expert AE knowledge to caseworkers, reimbursement specialists and fellow team members.

Review patient information in database and ensure accurate documentation. Attach post infusion reports to databases.

Assisting in reconciliation activities as per the program requirements/PV agreement.

Generating CAPA’s/issue reviews upon process deviations, ensuring cohesiveness and overall quality of the report.

Assuring awareness and training of pharmacovigilance team for project-specific scope, supporting start-up of new projects, including identification of potential risks and drafting mitigation strategies for seamless delivery of service at conduct stage

Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.

Provide Medical Information (inquiries and product quality complaints) for client projects that require this service.

Assist with User Acceptance Testing (UAT) including script development and testing, as applicable, and maintenance of validation documentation in accordance with governing documents. Pharmacy Assistant, Shoppers Drug Mart, Canada Oct 2019 to Dec 2019

Responsible for all administrative duties related to the scheduling, distribution and dispensing of medications.

Generation of medication labels to enable timely dispensing and delivery.

Collation of dispensing documents according to Pharmacy regulations and set procedures.

Accurate labeling of medications for review by the pharmacist

Checking of final product for absence of particles floating in final compound Senior Pharmacovigilance Specialist, Parexel International, India Apr 2013 to Feb 2019 ICSR experience

Handling of safety mailboxes and fax machines for receipt of adverse events from different sources and responding them with acknowledgement of receipts after entry into the database.

Management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies, and solicited programmes) which includes management of serious adverse event (SAE) case processing workflows and case assignments for new initial or follow-up safety cases received, ensuring timely processing steps by the PV team members, which includes case triage, data entry, narrative writing, quality review, medical review, and submission of cases.

Hand on experience with Oracle Argus Safety database, including case processing and generating reports/line listings from the database.

Experienced in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”.

Maintaining a good working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations data entry conventions and guidelines, clients’ procedures, and international drug safety regulations.

Assist with tracking of cases through the PV workflow and monitoring adherence to processing timelines as detailed in the SMP and according to client and global regulatory requirements.

Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines as well as data integrity.

Monitoring the compliance by monitoring the standardized ICSR lateness reasons and associated corrective and preventive plans.

Communicated with external affiliates, health care professionals, physicians, and invigilators to investigate and follow-up on ADR reports during clinical trials, post-marketing and in the literature.

Literature training: Experienced in review and validity assessment of literature abstracts and full articles.

Working knowledge of safety databases (AWARE, ARGUS and SCEPTRE)

Experienced in handling cases involving medical devices.

Participated in audit and ensured that all the processes and required documentation are being carried out according to official documents and guidelines. Query management: Experienced in interacting with client personnel to resolve issues related to the processing of ICSRs in accordance with clients’ policies in a timely manner. Mentoring experience: Perform training for new PV staff, including but not limited to: PV governing documents, use of Argus Safety, including preferred data entry procedures, and case processing procedures and workflows. Mentor and develop PV staff for case processing standards and efficiency, ensuring accurate reporting of safety cases.

Quality Experience: Quality Control: Performed quality review of ICSRs to ensure high quality of the safety reports in accordance with the client SOPs and regulatory requirements. Aggregate reports experience

Preparation and writing of aggregate periodic safety data reports including Periodic Benefit Risk Evaluation Reports (PBRERs), Semi-Annual Safety Reports (SASRs) and Clinical safety statements.

Assisted the Global Safety Officer in the preparation, review, and evaluation of signals.

Sending queries to and liaising with the relevant client personnel regarding discrepancies for obtaining incomplete/missing information with a view to resolve and clarify issues and facilitate processing of the reports.

Retainer, Ranbaxy labs, product development and research, Gurgaon Sep 2012 to Apr 2013

Pre-formulation and formulation development involving ANDA submission of stable, reproducible, bioequivalent and production scalable generic solid dosage forms.

Product development for various pharmaceutical markets viz. US, EU, India, China, WHO, PEPFAR etc. according to their Regulatory requirements starting from the formula design till the filing and launch of product in the market.

Achievements:

• Acting as a local safety officer (Canada) and main point of contact for health Canada for a major pharmaceutical portfolio.

• Got special recognition in AmerisourceBergen Drug Safety and Information quarterly newsletter for important contribution to team in just 3 months of joining the company.

• Received appreciation emails from client for successful audit when very minor findings were received which were rectified quickly

• Excellent feedback received from Sponsors of assigned project per Customer Satisfaction survey result and appreciation from during Global Team meeting.

Education

Master of Pharmacy, Punjab technical University, 2010-2012

Bachelor of Pharmacy, Kurukshetra University, 2006-2010 Skills

Can communicate effectively in English with excellent presentation skills.

Advanced knowledge of MD office - word, Excel, PowerPoint, and Adobe software

Detailed knowledge of medical terminology

Proactive with problem solving skills and leadership abilities to meet deadlines.

Detail-oriented, customer- and quality-focused with strong attention to detail

Experience supervising and training direct reports.

Hands-on experience working on Salesforce and Veeva Vault

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