PS
Paramita Saha
Project Manager, Lead Pharmacovigilance Auditor and Consultant at Independent Service Provider / Freelance
Pune, IndiaWork Experience
Project Manager, Lead Pharmacovigilance Auditor and Consultant
Independent Service Provider / Freelance
Mar 2022 - Present -3 yrs, 2 months
India
- Job Details:Handling PVQA auditing, preparing audit programs, managing regulatory authority inspections, and providing QA support for GCP regulatory authority inspections.
Indian Institute of Clinical Research & Management (IICRM Pvt. Ltd)
Feb 2021 - Mar 2022 -1 yr, 1 month
India
- Job Details:Manage the clinical research department, conduct classes, oversee team tasks, and provide leadership in clinical research settings.
Senior Advisor - Pharmacovigilance
Dysmech Clinical Services Pvt Ltd
Jan 2020 - Oct 2020 -9 months
India
- Job Details:Guide the team for skill development, provide technical support, and facilitate projects and workshops.
Senior Pharmacovigilance Associate
Apcer Pharma India Limited
Feb 2015 - Jun 2019 -4 yrs, 4 months
India
- Job Details:Quality review of ICSRs, literature review, and management of compliance with SOPs and regulatory requirements.
Education
Bachelor's Degree in Microbiology
East West College of Management and ScienceJan 2007 - Jan 2009 - 2 yr
Bachelor's Degree in Botany (Hons), Zoology and Chemistry
Arya vidyapeeth collegeJan 2004 - Jan 2007 - 3 yr
Skills
- Pharmacovigilance
- Clinical data management
- ICH-GCP
- MedDRA
- RDC Studies
- GVP Audits
- Good pharmacovigilance practices (GVP)
- Literature Monitoring and Review
- regulatory compliance
- Oracle Clinical (OC)
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Languages
English
FluentHindi
Fluent