Sneha Choudhary
Perth,WA
Summary
Experienced Pharmacovigilance professional adept in Local & Global pharmacovigilance systems, offering expertise in Project Management, PV operations, and patient-centric solutions.
Overview
7
7
years of professional experience
Work History
Project Team Lead & Deputy QPPV
Commercial Eyes Pty Ltd
05.2022 - Current
- Managing client setup, contracts, and serving as QPPV/CPPV/Primary point of contact for over 10 clients.
- Applying SME expertise to ensure accurate reporting of Adverse Events and Product Complaints.
- Monitoring project activities, delivering reports aligned with KPIs and timelines, fostering client satisfaction.
- Proactively adress emerging safety issues, offering strategic guidance to manage regulatory implications.
- Contributed to audit preparations, enhancing compliance across departments and business units. Recently participated in TGA PV inspection.
- Led identification of potential clients, crafting persuasive proposals, and building industry networks through events/conferences, resulting in short and long-term business opportunities.
- Directed and empowered a skilled pharmacovigilance team, overseeing recruitment, training, assignments, and performance metrics, to ensure exceptional service delivery, professional growth, and enhanced outcomes.
Drug Safety Associate
Commercial Eyes Pty Ltd
03.2021 - 05.2022
- Case processing and Regulatory Authority reporting/submission
- Batch trending reports and signal detection
- Literature Surveillance including local and global literature
- Project management
- Configuration of safety database with study and client-specific requirements
- Reconciliations
- PV Report writing
- Standard Operating Procedures (SOPs) writing and creation of training material.
Community Volunteer
People Who Care
10.2020 - Current
Pharmacovigilance Scientist
PAREXEL International Pvt Ltd
03.2018 - 09.2019
- Management of all the pharmacovigilance activities including collection, review, follow up, tracking and reporting of adverse events within the required timeframe in line with Pharmacovigilance concepts (MedDRA coding, WHO-Drug Dictionary coding) and Reporting guidelines (FDA, ICH, EMEA, and other international guidelines)
- Detailed knowledge of GCP and ICH guidelines including a basic understanding of regulatory requirements for clinical research and Pharmacovigilance
- Experienced to liaise with local affiliate departments to ensure compliance with Product Safety and Risk Management and local pharmacovigilance standard operating procedures
Medical Writer
IDS Infotech Limited
08.2016 - 03.2018
- Provided personal assistance to the US physicians by gathering information for the patient's visit and partnership with the primary healthcare providers to deliver the pinnacle of efficient patient care
- Specialization in charting physician-patient encounters into the Electronic Health Record System in real-time by classifying and coding diseases according to an established classification system also utilizing Micromedex
- Specialization in high quality documentation of physical examination findings and procedures as performed by the physician using medical terminology
- Followed HIPAA guidelines and other legal documentation requirements
- Achieved DAC (Doctor-Approved Certificate) for three US physicians at Catholic Health Initiatives
- Trained on the job trainees to become efficient and competitive medical scribes.
Education
Master of Science - Biotechnology
Banasthali University
Jaipur, Rajasthan2016
Bachelor of Science - Biotechnology (Honours)
Choudhary Charan Singh University
Meerut, Uttar Pradesh2014
Skills
- Pharmacovigilance Expertise
- Literature Surveillance
- Signal Management
- Auditing and inspection-readiness
- Project & stakeholder Management
- Knowledge of ARISg, ARGUS, AWARE, TARA and Veeva database/system
- Consulting
- Good written and verbal communication skills
- Computer literacy with typing speed of 75 WPM
- Advanced proficiency in Microsoft Office applications
Timeline
Project Team Lead & Deputy QPPV
Commercial Eyes Pty Ltd
05.2022 - Current
Drug Safety Associate
Commercial Eyes Pty Ltd
03.2021 - 05.2022
Community Volunteer
People Who Care
10.2020 - Current
Pharmacovigilance Scientist
PAREXEL International Pvt Ltd
03.2018 - 09.2019
Medical Writer
IDS Infotech Limited
08.2016 - 03.2018
Master of Science - Biotechnology
Banasthali University
Bachelor of Science - Biotechnology (Honours)
Choudhary Charan Singh University
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