Clinical Research Safety

Skill Profile Summary

Six (*) years of experience in international Pharmacovigilance (Domestic and foreign Individual Case Safety Reports, Safety Aggregate Reports, Literature Search for Adverse Drug Reactions (ADR) Reporting, Spontaneous and Clinical Trial cases, Mandatory Reporting for Device Devices). Almost 2 years of Canadian Pharmacovigilance experience.

Excellent clinical judgment and ability to communicate complex clinical issues both orally and in writing.

Assisted in preparation of Pharmacovigilance and risk management reports to clients.

Provided strategies for development of safety plans and supported activities related to pharmacovigilance agreements such as SDEAs.

Beginners French language knowledge (continuing).

Professional Background

Pharmacovigilance Team Lead

Canadian Cancer Trials Group (CCTG), Queens University 2019- 2019

Develop and implement SOP’s and Work Instructions

Oversee and assess the training and education of staff and external network

Oversee all pharmacovigilance activities to ensure compliance with regulatory guidelines

Assisted in signal detection and preparation of Pharmacovigilance and risk management reports through consultation with trial Investigators

Review, preparation and contribution to safety related questions from health authorities, ethics committees, IRB’s or external partners

Maintain knowledge of, and updates organizational leadership teams and policies and processes, all applicable regulatory guidance nationally and internationally regarding safety including changes

Manage the safety oversight processes of the group to ensure effective and compliant implementation of agreed safety reporting plans

Ensure all amendments to Product Monographs and Investigator Brochures and, together with the responsible Senior Investigator, provide recommendations regarding Protocol and Informed Consent Updates, and ensure timely implementation

Ensure appropriate interaction with Health Canada and other regulatory bodies with regards to pharmacovigilance activities

Assisted in preparation, negotiation and maintenance of SDEA and Pharmacovigilance Agreements.

Manage performance by establishing performance standards, review and evaluate performance and conduct formal performance reviews on an ongoing basis

Develop and implement a quality plan for pharmacovigilance processes and report to the Manager, OCO

Pharmacovigilance Specialist and Individual Contractor 2018 - 2019

Crown Medical Research and Pharmaceutical Sciences College of Canada

Designing, writing and review of SOPs as per ICH guidelines.

Triage, registration and data entry of Adverse Drug Reactions into safety database as per Health Canada regulations

Responsible for responses to health authoritie’s queries

Follow up with study personnel for queries and additional data for reporting

Reconciliation of safety data

Pharmacovigilance Associate 2013- 2017

Parexel International, Chandigarh, India

Performed Data Management of an average of thirty-five (35) ICSR which included:

Triage of adverse event reports to determine whether they qualify for expedited reporting and submission timelines

Conducting duplicate searches prior to registration and identifying potential duplicates

Registration or archiving of ICSRs into the safety database

Data entry of ICSRs in the safety database, including determination of the expectedness of adverse events against various labeling documents (Product Monograph, SPC, CCDS, IB etc.), writing case summaries, assessing causalities and writing company comments

Data validation and cross checking against source documentation

Completed medical review of cases based on expectedness, listedness and seriousness in compliance with regulations and international guidelines

Corresponded with clinical trial coordinators, health care professionals for follow-up queries to ensure completion of patient case details

Assisted in development of safety action plans and provided proactive risk assessment

Kept current with drug regulations, revised SOPs and working instructions and labeling updates

Expertly handled applications like MedDRA and WHO drug browsers to support accurate evaluation of ADR’s, patient medical history, past drug history and other drug indications

Completion and implementation of CAPA to ensure compliance

Imparted training to Pharmacovigilance personnel on regulations, guidelines, ADR case data entry and quality review leading to their smooth and effective initiation in the team

Professional Training

Crown Medical Research and Pharmaceutical Sciences College of Canada

Certificate in Drug Safety and Pharmacovigilance ICH-GVP (E2) and Adverse Events Reporting. 2018

Certificate in ICH-GCP (E6). 2018

Certificate in Legislation and International Guidelines for Bio-Ethics in Pharmaceutical Clinical Research. 2018

Certificate in Fundamentals of Drug Development Process and Pharmaceutical Clinical Research. 2018

Academic Background

Postgraduate Certification in Clinical Research Management, Drug Safety and Pharmacovigilance, Crown Medical Research and Pharmaceutical Sciences College of Canada. 2018

M.Sc. in Clinical Research, Cranfield University, UK. 2012

B. Pharmacy, IKG Punjab Technical University, Punjab, India. 2010

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