Nikita Rita
Global Safety Lead at Takeda
- Role
- Medical Director at Takeda
- Location
- Arlington, MA, US
- LinkedIn followers
- 500 followers
About Nikita Rita
Patient-centered pharmaceutical executive, strategic thinker with the flexibility and determination to address evolving business demands and challenges. A multifaceted team player with hands-on experience in safety management of pharmaceutical products. Proven expertise in the preparation of aggregate safety reports on marketed products including PSURs, DSURs and INDs. Experience in the development of clinical study protocols, safety monitoring in clinical studies and the preparation of clinical study and clinical safety reports. Experience in regulatory filings including INDs and NDAs. Experience in the development of RMPs and REMs to meet postmarketing/post-approval commitments for pharmaceutical products. and in the preparation of responses to regulatory agencies and competent authorities including request for supplemental information (RSI). Experience in developing safety strategies for Advisory Committee Meetings.I am constantly seeking out opportunities which will develop me as a person into the best version of myself. Regulatory Affairs and Drug Development plays an important role in developing novel drugs to meet the unmet medical needs and I hope to contribute to it in a positive way. Specialties:Clinical Operations | Research & Development | Strategic Planning & Execution | Pharmacovigilance | Regulatory Affairs I Vendor Management I Therapeutic Expertise:Gastro-endocrinology, Rare diseases, Oncology, Hematology, Cardiovascular and Women\'s healthcare
Experience
Medical Director
Mar 2023 — Present · Cambridge, MA, US
Education
Northeastern University
Masters in Regulatory Affairs of Drugs and Medical Devices, Pharmaceutical Sciences
2017 — 2018
Medical jobs updates
Bachelor of Medicine, Bachelor of Surgery (M.B.B.S.)
2005 — 2011
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.