Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
References
Timeline
Generic
Piyush Rawat

Piyush Rawat

Brantford,ON

Summary

Results-driven pharmacovigilance leader with a track record in regulatory compliance and quality management at Cencora. Expertise in data analysis and communication facilitates process enhancements and team performance improvements. Achieves audit readiness and client satisfaction through meticulous safety reporting. Committed to nurturing employee growth in high-pressure environments.

Overview

13
13
years of professional experience

Work History

Manager, Pharmacovigilance and Medical Information

Cencora (Innomar strategies)
, Canada
11.2021 - Current
  • Acts as a 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)
  • Act as the primary point of contact for Innomar clients while overseeing all pharmacovigilance and Medical Information call center activities
  • Provides support with the handling of medical inquiries; Acts as the scientific expert and as the escalation point for triage of medical inquiries from the medical information call center
  • Leading team meetings as required: presenting data, process changes or updates to the team and addressing any concerns or questions.
  • Quality Management activities: 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).
  • Ensure PV processes follow all ICH-GCP guidelines, current global regulations, and contractual agreements with our clients.
  • Close interaction with other departments across company (Clinical Operations, Data Management), Regulatory, Quality Assurance, Program) and clients
  • Management of Standard Operating Procedures, policy documents and processes relevant to PV and cross-departmental throughout process life cycle management. Assist with the periodic review of PV governing documents such as SOPs, Policies, and Work Instructions.
  • Responsible for the maintenance of the Key Performance Indicators and improvements in the process of compliance.

Senior drug safety associate (Project lead)

Cencora
, Canada
12.2019 - 10.2021
  • 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 project scope and objectives based on the signed agreement between the client and. Cencora
  • 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
10.2019 - 12.2019
  • 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
04.2013 - 02.2019
  • 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.

Associate, Product Development and Research

Ranbaxy labs
Gurgaon, India
09.2012 - 04.2013
  • 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 to the filing and launch of the product in the market.

Education

Master of Science - Pharmacy

Punjab Technical University
India
08-2012

Bachelor of Pharmacy -

Kurukshetra University
India
08-2010

Skills

  • Effective communication
  • Quality management
  • Data analysis
  • Pharmacovigilance
  • Presentation skills
  • ARGUS Enterprise expertise
  • Microsoft Office proficiency
  • Adobe software expertise
  • Medical terminology expertise
  • Process improvement
  • Decision-making
  • Leadership abilities
  • Employee development
  • Customer focus
  • Training and development
  • Salesforce expertise
  • Veeva Vault proficiency
  • Medical inquiry handling
  • Team leadership
  • Client relationship management
  • Project management
  • Regulatory compliance
  • Issue resolution
  • Audit readiness
  • Performance management
  • Team building

Accomplishments

  • Got special recognition in Cencora 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.

Languages

English
Full Professional

References

References available upon request.

Timeline

Manager, Pharmacovigilance and Medical Information

Cencora (Innomar strategies)
11.2021 - Current

Senior drug safety associate (Project lead)

Cencora
12.2019 - 10.2021

Pharmacy Assistant

Shoppers Drug Mart
10.2019 - 12.2019

Senior Pharmacovigilance Specialist

Parexel International
04.2013 - 02.2019

Associate, Product Development and Research

Ranbaxy labs
09.2012 - 04.2013

Master of Science - Pharmacy

Punjab Technical University

Bachelor of Pharmacy -

Kurukshetra University

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Piyush Rawat