Medical Safety

Dr. Kritika Mehta

Contact: 437-***-****

adcwej@r.postjobfree.com

Etobicoke ON

Summary:

• Dental professional with an experience of 5 years in the field of pharmacovigilance with expertise in aggregate safety data review.

• Assist in the triage of literature cases.

• Skilled in applying applicable clinical research regulatory requirements such as GCP and GVP guidelines.

• Expertise in medical review of the aggregate reports and signal management.

• Have a good knowledge about Health Canada regulations mostly related to Pharmacovigilance. Skills:

• Literature ICSR assessment and quality review of ICSRs.

• Expertise in generation of line listing, eRMR reports and ICSR forms from EudraVigilance database.

• Advanced processing skills in MS Word/Excel.

• Able to work effectively across cultures and in a virtual environment

• Good understanding of CIOMS, ICH-GCP guidelines, GVP and Health Canada regulations.

• Well versed with GVP Module VII – Periodic safety update report

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.

• Knowledge of ARGUS safety 8.0

• Well versed with the MedDRA browser.

• Excellent verbal and written communication skills honed over a year of experience.

• Ability to work independently and under pressure. Professional experience:

Apotex Pharmaceutical, North York, ON Nov 2019- Present Associate, Global Pharmacovigilance

• Perform medical review of ICSRs and generate follow-up questions as appropriate.

• Review literature articles for assessment of ADRs.

• Reconciliation of event reports

• Assist in Audit preparation

• Support the team in any query related to ICSR literature review for triage.

• Perform expectedness and listedness assessment and ICSR reportability.

• Respond to Health Canada, ATI requests.

• Contribute to submission of clinical study cases to DCGI. Mylan Pharmaceutical Pvt. Ltd.

(US Based organization, based in Hyderabad, India) Feb 2018 - Oct 2019 Drug Safety Physician

• Preparation and review of clinical overview addendum (COA) to support PI updates.

• Periodic Safety Update Reports (PSURs)in accordance with current regulations to ensure the maintenance of product safety.

• Participate and provide medical input in periodic safety meetings

• Assist in preparing response to the regulatory authority questions related to safety issue (RTQArticle31)

• Signal management including medical review of signal reports, generation of EVDAS line listing and eRMR reports.

• Medical review of AE cases.

• Preparation of risk management plan (RMP)

• Writing and update to the standard operating procedure (SOP) and work instructions (WI).

• Training to new employee and team members (Training on EudraVigilance platform). Sun Pharmaceuticals Ltd. (Gurgaon, India) Jun 2016 – Feb 2018 Drug Safety Physician

• Preparation and review of Periodic Safety Update Reports (PSURs)/PBRERs.

• Medical Review of Periodic Adverse Drug Experience Reports (PADER)for submission to USFDA.

• Literature search patent search and review, PIL, Daily med, Drug index, FDA, SPC and Reference books, etc.

• Generation of Line-listings from Argus safety database.

• Ensure inspection readiness by maintaining compliance with applicable working practice documents (WPDs), SOPs, regulations and guidelines.

• Team initiatives like knowledge sharing exercises and documentation of resources.

• Providing medical review training to all staff and new employees. Cigna Healthcare Insurance (US Based MNC based in Gurgaon, India) Oct 2015 – Jun 2016 Dental Reviewer (Dental Claims review and processing)

• Claims processing through analysis of dental reports, x-rays and diagnosis.

• Following up with onshore teams and providing all the necessary supports, documents through email.

• Identification of fraud and suspicious claims.

Manav Rachna Dental College Oct 2014 - Oct 2015

Dentist

• Examining patients and suggesting suitable treatment plan.

• Patient preparation and intraoral examination

• Full mouth rehabilitation including extractions, scaling and polishing, dental x ray, full and partial dentures. Projects:

Signal Management Project

• Screening and medical review of eRMR reports

• Generation of EVDAS line listing, eRMR reports and ICSR forms (L2a and L2b)

• Analyzing the quarterly data of Signals of disproportionate reporting

• Review of literature articles from business partners and potential signal notification form as a part of signal detection

• Maintaining signal validation and assessment tracker and compliance of signal reports.

• Trainings on EudraVigilance platform and it’s practical use in signal reports and EU PSUR. Awards and Recognition:

• Have been recently promoted as Research Manager after 6 months of joining.

• Have received accolades and appreciations via email from my manager for working efficiently and performing all the tasks, Ad-hoc within SLA's.

Education and Certifications:

• Bachelor of dental surgery from Pandit Bhagwat Dayal University, India (2010-2015)

• Registered dentist by Haryana dental council (India)

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