Madhavi Pardeshi
Assistant Manager @USV PRIVATE LIMITED
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WORK HISTORY
Assistant Manager @USV PRIVATE LIMITED
Mumbai, IN
Global Pharmacovigilance responsibility:• Preparation and review of aggregate report (PSUR/PADER/PBRER) for India / Emerging market.• Preparation of Risk management plan of generic molecule for India and Emerging market and review of bio-similar RMPs for UK MHRA/EU.• Review of Signal management reports• Literature monitoring, review of articles and reporting to PvPI• Reconciliation activities with domestic and international partners.• Maintenance, archival and reporting of ICSRs in India. Review of AE reports (i.e.Medwatch/CIOMS forms) for US and India.• Preparation, maintenance of PV SOPs and findings for more effective standard procedures for improvement of PV compliance.• Co-ordination and follow up with external PV stake holders (vendors and service providers) for PV activities/queries.• Identify and resolve core PV issues.• Communicate and interact effectively within and across all other departments• Maintaining complete PV records as per internal standard procedure and regulatory requirements.• Preparation and review of PV master file of India and UK MHRA respectively.• Preparation and review of PV agreements (i.e SDEA /MOU) with different stake holders.• Providing PV training to internal team and external stake holders.• Faced USFDA inspection of PV function and conducted virtual audit of service providers.Regulatory support responsibility:• Prepared clinical documentary requirements of CTD Module 2 as per ICH/EU guidelines for EU and emerging markets. Non-clinical Overview (Module 2.4)
EDUCATION
Ves college of pharmacy
Bachelor of Pharmacy (BPharm)
Dr. Bhanuben Nanavati College of Pharmacy
Master of pharmacy, Pharmacology
Dr. Bhanuben Nanavati College of Pharmacy
Master of pharmacy, Pharmacology
SKILLS
ABOUT MADHAVI PARDESHI
Result-oriented Pharmacology post-graduate (M. Pharm) with 10 years of robust experience…
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