Shivani Thakur

To pursue a challenging career in clinical research / Pharmacovigilance related to acquired skills and knowledge of regulatory affairs, Individual Case Safety Report (ICSR) and other FDA related documents. Efficient professional with 2.5 years of experience and a proven knowledge of regulatory affairs, data collection and analysis of Individual Case Safety Report forms. Accustomed to working with project teams, and providing research and advice on compliance with federal laws and FDA regulatory guidelines and SOP preparation. Skilled in CMC Regulatory, mainly in CTD reports and practical knowledge of ICSR case processing. Familiarity with drug and medical device regulatory submissions process - INDA, NDA, ANDA, DMF, ICH, CTD, 21 CFR, 510 (k), De Novo Submissions, Pre Market Approval (PMA) process and FDA QSR. Strategic thinker with strong attention to detail, excellent communication, writing, and interpretive skills. Ability to solve practical problems, to multi-task, to establish and maintain good working relationship at all levels.

• Clinical Trials Network Good Clinical Practices [ 01/01/2022 – 01/01/2025 ] Issued by: The National Institute on Drug Abuse (NIDA, NIH)
• Introductory course on Pharmacovigilance and Clinical Research Issued by : Uppsala Monitoring Centre
• Certificate Course in Drug Regulatory Affairs Issued by: Udemy
• Global Pharma Drug Regulatory Course Issued by: Udemy
• Practical Regulatory Affairs - 2020 USFDA Medical Devices Issued by: Udemy

J2-Employment Authorization Document Holder

Sponsorship Required: NO

• Bhumika Sharma (Former Manager) Senior Manager PAREXEL India Private Ltd. Email ID: bhumika.sharma@parexel.com
• Dr Gagan Deep Chaudhary (Former Manager) Senior Manger PAREXEL India Private Ltd. Email ID: chaudhary.gagandeep@parexel.com
• Paramjot Maman (Former Deputy Manager) Senior Pharmacovigilance Specialist xEVMPD Regulatory affairs PAREXEL India Private Ltd. Email ID: param.jot@parexel.com