CARLA XIMENA VELASCO LOPEZ
Graduate Pharmacovigilance Associate
Mexico City
Summary
Detail-oriented and proactive Pharmacovigilance professional with hands-on experience in case processing, MedDRA coding, and compliance with global regulatory guidelines (ICH, GVP, EMA). Proven track record in ensuring data quality, conducting literature reviews, and supporting safety reporting activities in line with company SOPs and regulatory timelines. Adept at working in cross-functional teams, prioritizing tasks under pressure, and continuously improving processes. Strong communication skills, analytical mindset, and a commitment to patient safety and data integrity.
Overview
2
2
years of professional experience
8
8
years of post-secondary education
Work History
Graduate Pharmacovigilance Associate
ICON, formerly PRA Health Sciences
Ciudad De México
05.2024 - Current
- Categorizing and triaging incoming safety information directed to the sponsor's Pharmacovigilance (PV) email, ensuring prioritization of safety events, including post-marketing reports and medical device incidents, for prompt action in accordance with project-specific protocols.
- Conducting detailed reviews and analyses of safety events and related information, utilizing MedDRA terminology for precise classification and thorough documentation that meets regulatory and organizational standards.
- Orchestrating timely internal reporting from affiliates to Global Safety, preparing comprehensive initial reports and follow-ups to enhance communication and compliance across the organization.
- Executing thorough literature reviews of abstracts and full articles to extract critical safety information regarding post-marketed products, supporting proactive risk assessment and contributing to data integrity.
- Engaging with Global Safety teams to address and clarify inquiries related to specific cases, fostering clear communication with reporters to ensure all received information is accurate and complete, thereby enhancing data quality and reliability.
- Implementing quality assurance processes by performing rigorous Source Data Verification (SDV) of processed cases, ensuring reported information meets high standards of accuracy and completeness.
- Managing case closures and responding to customer inquiries on technical complaints with professionalism, while reconciling safety cases received from various sources to maintain compliance with regulatory deadlines.
- Executing various administrative and pharmacovigilance-related tasks as assigned by management, including case closure, reconciliation of safety cases from different sources, preparation of external reports for local health authorities, and conducting quality checks of safety calls and medical inquiries.
Jr. Associate Specialist in Pharmacovigilance and Medical Device Vigilance
INSTITUTO DE EDUCACIÓN Y ASESORÍA EN CIENCIAS FARMACÉUTICAS Y FARMACOLÓGICAS
06.2023 - 04.2024
- Ensuring compliance with relevant Standard Operating Procedures (SOPs) and regulatory standards.
- Supporting the preparation and updating of documentary information for accurate safety data management.
- Evaluating received cases and determining classifications as Adverse Events (AE), Adverse Drug Reactions Monitoring System (ADRMS), Medical Adverse Reporting (AMR), and other drug safety issues, utilizing MedDRA terminology.
- Submitting cases on local and global platforms, as well as to health authorities (eReporting Industry)
- Assisting in the preparation of Risk Management Plans (RMP) to facilitate risk assessment and mitigation.
- Conducting follow-up calls with patients to obtain essential safety information on adverse event reports.
- Developing national and international Periodic Safety Reports, ensuring PSURs are prepared according to local regulations and ICH guidelines.
- Complying with activities described in NOM 220 to uphold pharmacovigilance practices.
- Providing training on pharmacovigilance and Devicevigilance to staff, promoting a culture of safety.
- Supporting annual customer planning and document scheduling to optimize resource allocation and project management.
Education
Certificate - Forensic Chemistry
Universidad Nacional Autónoma De México
Ciudad De México, México 03.2023 - 03.2025
Bachelor of Science - Pharmaceutical chemistry biologist
Universidad Nacional Autónoma De México
Mexico City, Mexico City 07.2016 - 12.2022
Skills
Analytical thinking
Effective communication
Adaptability and flexibility
Continuous learning mindset
Attention to detail
Analytical thinking
Timeline
Graduate Pharmacovigilance Associate
ICON, formerly PRA Health Sciences
05.2024 - Current
Jr. Associate Specialist in Pharmacovigilance and Medical Device Vigilance
INSTITUTO DE EDUCACIÓN Y ASESORÍA EN CIENCIAS FARMACÉUTICAS Y FARMACOLÓGICAS
06.2023 - 04.2024
Certificate - Forensic Chemistry
Universidad Nacional Autónoma De México
03.2023 - 03.2025
Bachelor of Science - Pharmaceutical chemistry biologist
Universidad Nacional Autónoma De México
07.2016 - 12.2022
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