CAROLINA HERENYI SILVEIRA
Charlottesville
Summary
Skilled Pharmacovigilance Consultant with 13+ years of experience in drug safety operations, including case processing, regulatory compliance, vendor selection, and safety system implementation. Successful track record leading cross-functional teams and managing complex projects, consistently meeting tight deadlines. Committed to enhancing patient safety through meticulous monitoring and proactive risk assessment. Proficient in using pharmacovigilance databases and tools like Argus and MedDRA.
Overview
15
15
years of professional experience
Work History
PV Consultant
Perspective Pharmacovigilance (PPV)
10.2020 - Current
- Supports for PV related study activities, such as facilitation of study documents such as IB, ICF, Protocol and Safety Management Plan
- Set up of SAE collection mechanism, query management, SAE reconciliation, and regulatory reporting matrix
- Facilitates safety reviews committees
- Provides expertise on workflow build, best case processing standards, templates, conventions, and process improvements
- Selects, trains, and oversees case processing vendor
- Supports development and implementation of pharmacovigilance systems and processes for client organizations
- Implements electronic data capture tools
- Supports vendor selection and implementation, from request for proposal to “go live.”
- Provides vendor oversight, including development of service level agreements and budget management
- Provided interim PV support for early-phase companies
- Creates roadmap and implements scale PV department build
- Establishes and maintains interfaces with other functions
- Supports development, benchmarking, and maintenance of PV budgets
- Facilitates implementation of a global safety database
- Supports safety system vendor selection and validation
- Provides expert advice on regulatory compliance, including FDA, EMA, and ICH guidelines
- Manages safety surveillance projects and ensures timely submission of periodic safety update reports (PSURs) and development safety update reports (DSURs)
- Collaborates with cross-functional teams to address safety concerns and ensure patient safety
Manager of Drug Safety Center (DSC)
PRA Health Sciences Inc.
06.2019 - 09.2020
- Led a team of pharmacovigilance specialists in the processing and evaluation of adverse event reports
- Developed and maintained standard operating procedures (SOPs) for pharmacovigilance activities
- Conducted signal detection and analysis using various data sources and statistical methods
- Prepared regulatory submission documents, including individual case safety reports (ICSRs) and DSURs
- Coordinated with clinical development and regulatory affairs teams to address safety-related queries
- Monitored compliance with global pharmacovigilance regulations and guidelines
- Processed and evaluated adverse event reports from clinical trials and post-marketing sources
- Conducted case assessments and determined causality and severity of reported events
Senior Drug Safety Associate/Supervisor of DSC
PRA Health Sciences Inc.
01.2016 - 05.2019
- Assisted in the preparation of regulatory submissions and safety reports
- Participated in signal detection activities and contributed to risk management plans
- Maintained pharmacovigilance databases and ensured data integrity and accuracy
- Collaborated with internal and external stakeholders to resolve safety issues
Drug Safety Associate
PRA Health Sciences Inc.
03.2011 - 12.2015
- Assisted in the preparation of regulatory submissions and safety reports
- Participated in signal detection activities and contributed to risk management plans
- Maintained pharmacovigilance databases and ensured data integrity and accuracy
- Collaborated with internal and external stakeholders to resolve safety issues
Clinical Research Coordinator
Kidney and Hypertension Hospital UNIFESP
01.2010 - 02.2011
- Coordinated and managed multiple clinical trials from initiation to closeout, ensuring compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements
- Conducted participant recruitment, screening, and informed consent processes, maintaining high enrollment rates and participant retention
- Scheduled and conducted study visits, collecting and documenting accurate data according to study protocols
- Managed and maintained study documents, including case report forms (CRFs), regulatory binders, and source documentation
- Liaised with sponsors, investigators, and regulatory authorities to facilitate study progress and address any issues
- Monitored study compliance, performed regular data quality checks, and ensured timely data entry into electronic data capture (EDC) systems
- Coordinated with laboratory and pharmacy staff for the timely collection and processing of biological samples and investigational products
- Conduct informed consent presentations and maintain documentation
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Education
Hospital Auditor Specialist - Quality Control And Safety
Uni Sao Paulo
Sao Paulo, Brazil01.2013
Undergraduate, Registered Nurse -
Centro Universitario Sao Camilo
Sao Paulo, Brazil01.2009
Skills
- Pharmacovigilance Systems Implementation
- Adverse Event Reporting
- Signal Detection and Risk Management
- Regulatory Compliance (FDA, EMA, ICH)
- Case Processing and Data Management
- SOP Development and Training
- Project Management
- Safety and Clinical Database
- Problem-solving
- Attention to detail
- Team leadership & development
- Client relationships
LANGUAGE/FLUENCY
Portuguese
Native or Bilingual
English
Full Professional
PROTOCOL THERAPEUTIC EXPERIENCE
- Cardio-Metabolic Diseases
- Gastroenterology (Esophageal Disorders)
- Hematology (Leukemia; Lymphoma; Multiple Myeloma)
- Immunology (Allergy; Autoimmune Diseases; Vaccine)
- Oncology (Solid Tumors)
SYSTEM EXPERIENCE
- CRF Design (paper)
- EDC (Medidata RAVE; BioClinica Espress)
- IVRS/WRS/RTSM/IRT (ClinPhone IVRS; Datalabs IVRS)
- Regulatory Publish Systems (EVWEB/Advarra/XEVMPD)
- Oracle AERS and ARGUS
- TMF (Documentum eTMF; NextDocs eTMF; Veeva Valt eTMF)
Timeline
PV Consultant
Perspective Pharmacovigilance (PPV)
10.2020 - Current
Manager of Drug Safety Center (DSC)
PRA Health Sciences Inc.
06.2019 - 09.2020
Senior Drug Safety Associate/Supervisor of DSC
PRA Health Sciences Inc.
01.2016 - 05.2019
Drug Safety Associate
PRA Health Sciences Inc.
03.2011 - 12.2015
Clinical Research Coordinator
Kidney and Hypertension Hospital UNIFESP
01.2010 - 02.2011
Hospital Auditor Specialist - Quality Control And Safety
Uni Sao Paulo
Undergraduate, Registered Nurse -
Centro Universitario Sao Camilo
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