Bina Patel, Rn, Bsn Email & Phone Number

League City, TX, US

Pleasanton, CA, US

DRUG SAFETY - Apply safety concepts and regulations contained within FDA CFR, ICH, and EU GVP to management of Safety data across the development life cycle; Participate in the set-up and maintenance of adverse event processes in global clinical trials; Perform Quality Review of the Individual Case Safety Report, including data and a concise, medically.

San Diego, California, US

Raleigh, North Carolina, US

Princeton, New Jersey, US

• Responsible for data entry, and querying, of serious adverse event (SAE) reports into Argus Safety Database
• Perform other relevant tasks and projects, including (but not limited to) participation in SAE reconciliation, team meetings, and filing of submission documentation.
• Ensure prompt and accurate processing of adverse event data.
• Provide accurate individual case reports for submission to regulatory authorities and participating clinical trial investigators in compliance with the regulatory time frames for reporting.
• Serves as member of project teams. Communicate timelines, provide deliverables and inform the project team on the status of activities and issues.
• Revise and maintain processes and procedures for drug safety in compliance with regulatory requirements and company standards.

Princeton, New Jersey, US

• Provide clinical and safety data assessment of reports from post marketing events involving Integra LifeSciences products
• Coordinate assessment and documentation associated with adverse reactions, product technical complaints and/or serious individual adverse events leading to a medical device report
• Provide responses (phone, written or email) for medical inquiries from consumers and HCPs
• Develop ongoing documents in response repository and review to identify emerging trends
• Provide cross-functional medical support to Integra’s family of companies
• Identify clinically significant information missing from initial reports and ensures its collection

Princeton, New Jersey, US

- Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. - entry of safety data onto adverse event database(s) and tracking systems- review of adverse events for completeness, accuracy and appropriateness for expedited reporting- write patient narratives- code adverse events.

Raleigh, North Carolina, US

• Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance
• Perform quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements
• Prepare safety data reports for submissions to clients
• Prepare and/or review Expedited Safety Reports for submission to Regulatory Authorities
• Communicate with Clinical Operations and clients to ensure compliance with safety and pharmacovigilance SOPs
• Assist with preparation of regulatory submissions reports, i.e., Annual Reports, Periodic Safety Update Reports

• Under direct supervision, designed, planned, developed, and monitored all phases of clinical trials
• Assisted with writing, editing, amending, and reviewing clinical trial documents, including protocol, sample ICF or operations manuals (e.g. monitoring plans, CRF completion guidelines, etc)
• Site management of clinical sites including training, protocol adherence and general correspondence
• Performed pre-study evaluation, site initiation, routine monitoring and close out visits to ensure compliance with the study protocol
• Developed and reviewed visit reports for completeness and accuracy
• Monitored clinical sites in accordance with all applicable guidelines and regulations

US

US

Conducted health screenings (B/P, Blood sugar, Osteoporosis, Skin Cancer, etc) for Middlesex county residentsSupported, counseled and educated patients and community as necessary

US

Served as staff nurse, preceptor and charge nurse on NICU, Medical-Surgical Unit and Transtional Care Unit