Anndriana Martinez
Budapest
Summary
Experienced healthcare professional with a background in safety surveillance, regulatory affairs and compliance. Skilled in managing global documentation, regulatory submissions, and trial disclosures. Proficient in ensuring compliance with health authority regulations, managing complex projects, and fostering cross-functional collaboration. Fluent in English and Spanish, with a proven ability to adapt to dynamic regulatory environments and deliver high-quality results within tight deadlines.
Overview
3
3
years of professional experience
Work History
Reference Safety Information (nRSI) Coordinator
Tata Consultancy Services
10.2024 - Current
- Manage the lifecycle of nRSI labels to ensure compliance, accuracy, and alignment with health authority (HA) approvals.
- Select appropriate reference labels based on medical judgment, study requirements, and SmPC criteria, maintaining updates in RIMS.
- Collaborate with global study teams, Safety Surveillance and Medical Team Leaders (SSaMTLs), and Global Safety Physicians (GSPs) to coordinate nRSI-related activities.
- Conduct impact assessments for MedDRA upgrades and submit amendments for HA approvals during annual reviews.
- Ensure robust documentation and record-keeping for all nRSI activities.
- Enhanced operational workflows by maintaining well-organized documentation systems and updating records accurately as needed.
Safety Surveillance Scientist
Tata Consultancy Services
06.2022 - Current
- Ensured compliance with global and local procedural documents and aligned with AstraZeneca’s safety objectives and policies.
- Assisted in maintaining up-to-date knowledge of AZ products, focusing on safety, efficacy, and pharmacological aspects.
- Conducted safety surveillance, reviewed aggregate case reports, and assessed literature in accordance with AZ search strategies.
- Evaluated safety signals using designated signal management tools and documented outcomes per AZ’s requirements.
- Prepared and summarized outputs for Cumulative Safety Assessment Meetings (C-SAM) and participated in safety strategy discussions.
- Delivered training sessions on updated safety plans, signal evaluation criteria, and product safety profiles.
Education
Bachelor of Science - General Dentist
José Antonio Páez University
VenezuelaSkills
- Safety Surveillance: Signal evaluation, Safety reporting, Literature review, Medical writing
- Technical Proficiency: MS Office Suite (Word, Excel, PowerPoint), MedDRA, OAS, Argus, Sapphire database, SMT, R&D, ERV
- Regulatory Affairs: Dossier preparation, compliance monitoring, health authority interactions
- Project Management: Process optimization, milestone tracking, KPI reporting
- Documentation and Quality Management: Metadata creation, CMS administration
- Languages: Fluent in English and Spanish
References
Raul Blonval
+36 30 013 6424
raulblonval89@gmail.com
Timeline
Reference Safety Information (nRSI) Coordinator
Tata Consultancy Services
10.2024 - Current
Safety Surveillance Scientist
Tata Consultancy Services
06.2022 - Current
Bachelor of Science - General Dentist
José Antonio Páez University
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