Cassandra David
Pharmacovigilance Consultant
- Role
- Pharmacovigilance Operations Lead at Reliant Life Sciences
- Location
- Suffolk County, MA, US
- LinkedIn followers
- 500 followers
About Cassandra David
A Clinical Research professional with a demonstrated history of success in the pharmaceuticals industry. Extensive experience in Pharmacovigilance and clinical trial management including Biotechnology, Phase 1-IV, including all aspects of clinical trial management, regulatory and ICH GCP compliance activities. Strong research, training, mentoring and mentorship skills. Recognized as an innovative leader with strong organizational and problem solving capabilities to drive success through collaboration with cross functional teams. A self motivated individual who has consistently delivered quality results and is driven by innovation
Experience
Pharmacovigilance Operations Lead
Jun 2024 — Present · Waltham, MA, US
PV point of contact responsible for managing CRO relationship and providing oversight of daily operations.• Assisting Clinical Development and Clinical Operations teams for start-up activities of new open label and Observational trials.Participating in the review and maintenance of PV SOPs, vendor/study plans, and product-specific documents,including the RSI, IB, CCDS, CCSI, USPI, SmPC).• Generating and reviewing metrics for case quality and compliance, monitoring for trends and possible improvements, and supporting weekly and monthly reconciliations.• Supporting aggregate report deliverables (overseeing data collection, quality reviews, and analysis process).• Cross functional interaction with members of Safety to address safety-related concerns, inquiries, and regulatory commitments.
Education
Boston University
Bachelor of Arts (BS), Psychology
1992 — 1996
Boston University
Bachelor of Arts - BA, Psychology
Massachusetts College of Pharmacy and Health Sciences
Graduate Certificate in Health Policy
2008 — 2009
Laboure College
Associate's degree, Nursing
2010 — 2013
Skills
- CRO
- Oncology
- Managed Care
- Clinical Development
- Medical Writing
- Medical Devices
- Clinical Research
- Regulatory Requirements
- Ind
- Ich-Gcp
- Nda
- Drug Development
- Gcp
- Biopharmaceuticals
- Glp
- Biotechnology
- Drug Discovery
- Infectious Diseases
- Clinical Trials
- Edc
- Therapeutic Areas
- Medical Affairs
- Ctms
- Regulatory Submissions
- Neurology
- Pharmaceutical Industry
- Sop
- Fda
- Drug Safety
- Pharmacovigilance
- Gmp
- Meddra
- Clinical Monitoring
- Clinical Data Management
- Regulatory Affairs
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