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Pratik SaykhedePS
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Pratik Saykhede

@pratiksaykhede

Pharmacovigilance Specialist in drug safety who processed and quality-reviewed ICSR cases across clinical trials and post-marketing sources.

India
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At Apcer Life Sciences, I processed and quality-reviewed safety reports using Global Intake Tool, managing ICSR workflows across clinical trial and post-marketing sources. I reviewed adverse event reports and source documents for reportability, completeness, and data quality.

I also supported follow-up activities, MedDRA coding, and reconciliation between drug safety and clinical trial databases. I supported management during regulatory inspections and internal quality audits.

At Tata Consultancy Services, I handled initial and follow-up pharmacovigilance transactions and prepared safety narratives in line with departmental SOPs. I processed expedited cases and initiated follow-up when information was delayed, missing, or incomplete.

At Inventurus Knowledge Solutions, I reviewed and validated clinical data and supported medication information transfers, including E-Clinical Works patient information. I also founded PharmaPath, where I provide one-on-one career counselling and mentorship to pharmacy students.

Experience

Work history, roles, and key accomplishments

Education

Degrees, certifications, and relevant coursework

SU

Savitribai Phule Pune University

Bachelor of Pharmacy, Pharmacy

2014 - 2018

Bachelor of Pharmacy degree from Savitribai Phule Pune University, completed from 2014 to 2018.

CE

Central Board of Secondary Education

Secondary School Certificate

2001 - 2012

Secondary School Certificate from the Central Board of Secondary Education, completed from 2001 to 2012.

Tech stack

Software and tools used professionally

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