More than 4+ years of diverse experience in PV and QA

Experiences

Cognizant Technology Solutions (Novartis Oncology) Mar 2016 to Sep 2018

Management of ICSRs of all types of cases including triage, coding and data validation. Maintaining excellent knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, Data entry conventions and guidelines, client’s procedures and international drug safety regulations.

Expertise in handling safety database (like Argus Affiliate and Argus Core)- global pharmacovigilance software designed to support the reporting and management of adverse events from clinical and post-marketing sources ensuring global regulatory compliance.

Verification and expertise of the accuracy of MedDRA and WHO- DD coding.

Creation of comprehensive case descriptions (narrative) in English language extracting relevant pharmacovigilance information.

Training experience: Certified training form Novartis. Helps associates to get project on-boarding in post marketing (Oncology) teams (approx. 200 trained associates). Provides trainings for huddles (associated with major quality errors) and reference safety information document update to all associates of project. Keeps a check on overall training related compliances for project.

Provide support and coordinate in major audits.

Well-versed with ICH-GCP guidelines, GVP, FDA, CIOMS, SOP's, audits/inspections and regulatory requirements.

Case processing: Solicited and unsolicited Serious and Non Serious cases. Processed approx. 3000 plus case with more focus and expertise on complex and critical case included discharge summaries, pregnancy cases, compassionate cases, etc .

Mylan Laboratories Ltd. – Apr 2014 to Nov 2015

Stability - Protocol preparation, review and execution

PASC Preparation – US, Canada, WHO, PEPFAR

Review and Closure of stability tasks in Sparta-Trackwise

Perform SAP transactions

BPCR Review

IPQA Activities – Line Clearance, In-process parameters, sampling as per BPCR requirements, qualification and validation, calibration schedule, Investigate and report deviations, Cleaning process

Sending Samples – Bio, Query, R&D to FDS

Quality Systems – cGMP, GDP

Regulatory Experience and Knowledge

Education

200*-****-**** 201*-****-**** 2013

Awards

Interests

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Akanksha Shah

More than 4 years of diverse experience in the fields of Pharmacovigilance/

Drug Safety/Quality Assurance

B.Pharm, Bhopal

RKDF School of Pharmaceutical Sciences

M.Pharm, Bhopal

VNS Institute of Pharmacy

GPAT – Rank 8000

Ministry of Human Resource Development Scholarship for Post-graduation

Best Presentation at Pharmaexhibi 2010 –Bhopal

Reading Novels

Common Technical

Data

Pharma Guidelines

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