Nidhi Prem
Global Head of Pharmacovigilance at Calico Life Science
- Role
- Global Head of Pharmacovigilance at Calico Life Sciences
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About Nidhi Prem
Drug Safety Physician with over 15 plus years in the pharmaceutical industry, who has experience in drug safety/pharmacovigilance, strategic PV & risk planning, clinical research, regulatory affairs, FDA & EMEA/MHRA/AFSSAPS interactions, ICH, compliance, training, risk management, drug safety crisis management & electronic data capture. During my tenure as a pharmaceutical physician, build safety organizations considered among the best in the industry, in addition to putting the necessary organization, procedures and system in place for ensuring compliance with global regulatory requirements and who has extensive experience managing important product safety issues from medical and regulatory perspective. Demonstrated success in providing expertise for regulatory, study design, protocol, standard operating procedures (SOPs), risk management, data analysis, and submissions of INDs, NDAs, ANDAs to the FDA for approval. Specialties• Drug Safety & Pharmacovigilance (Operations, Strategy & Planning)• Drug Safety Management Boards, Risk Management & Safety Crisis Management• Management Consultancy and Organization Excellence• CRO, Medical & Regulatory Training• Drug Safety Outsourcing • Leadership Development• PV Audits and Mock Inspections• Compliance & Quality Management• Clinical Development
Experience
Global Head of Pharmacovigilance
Jan 2023 — Present · San Francisco, CA, US
Education
Himalayan Institute of Medical Science
Bachelor of Medicine and Surgery (M.B.B.S; M.D, to
1995 — 2000
Himalyan Institute of Medical Science
MD, Bachelor of Medicine and Science
1996 — 2001
Skills
- Clinical Study Design
- Pharmaceutics
- Clinical Trials
- Pharmacovigilance
- Ich-Gcp
- Sae Reconciliation
- Medical Affairs
- Oncology
- Cardiology
- Protocol
- Cra
- Biotechnology
- Pharmaceutical Industry
- Sop
- Fda
- Drug Safety
- Clinical Development
- Medidata
- Clinical Research Associates
- Management
- Regulatory Affairs
- Quality Assurance
- Clinical Monitoring
- Clinical Data Management
- Oracle Clinical
- Data Management
- Ind
- Crf Design
- Medical Devices
- Clinical Research
- Medical Writing
- Biostatistics
- Hematology
- Diabetes
- Meddra
- Infectious Diseases
- Edc
- Therapeutic Areas
- Neurology
- Ctms
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