Romelyn Bollido

Licensed Pharmacist and Pharmacovigilance professional with hands-on experience in end-to-end case processing, including intake, triage, data entry, medical review, and expedited reporting of adverse events. Proven ability to manage Individual Case Safety Reports (ICSRs) from multiple sources (spontaneous, literature, clinical trials, regulatory) strict global timelines. Strong expertise in MedDRA coding, narrative writing, and quality review aligned with GVP guidelines.

Adept at working within quality management systems and collaborating across cross-functional teams to ensure regulatory compliance and patient safety.

Associate, Case Processing (Pharmacovigilance) - ClinChoice Inc. - Ortigas, Pasig City

(2025-11 - 2026-05)

• Perform case intake, duplicate search, and triage of safety reports from spontaneous, literature, clinical trial, and regulatory sources.
• Conduct accurate data entry into safety databases, including seriousness, causality, listedness, medical history, laboratory data, and adverse events using MedDRA coding.
• Draft and review high-quality patient narratives, ensuring medical accuracy and regulatory compliance.
• Perform quality control (QC) and medical review of cases, validating data accuracy, coding consistency, and completeness of documentation.
• Support expedited reporting of Serious Adverse Events (SAEs) to clients and regulatory authorities within defined timelines.
• Execute literature search and screening to identify reportable safety cases and support signal detection activities.
• Generate and follow up on queries to ensure completeness and accuracy of case data.
• Contribute to process improvement initiatives, SOP development, and client onboarding activities.
• Maintain working knowledge of GVP modules and global regulatory requirements.

Regulatory Affairs Associate / Pharmacist - Experto Gamefowl Products Inc.

(2024-04 - 2025-04)

• Prepared and compiled regulatory dossiers for product registration under FDA, BAI, and FPA frameworks.
• Led Foreign Good Manufacturing Practice (FGMP) desktop evaluation, resulting in FDA approval and successful product registration.
• Managed regulatory submissions, variations, and licensing for veterinary medicinal products.
• Coordinated with regulatory agencies to resolve importation issues and secure SPS-IC permits.
• Ensured compliance with evolving regulatory requirements and documentation standards.

Store Supervisor / Pharmacist (OIC) - Generika Drugstore

(2023-04 - 2024-04)

• Identified and monitored potential adverse drug reactions (ADRs) during patient counseling and dispensing.
• Ensured accurate documentation and compliance with pharmacy and healthcare regulations.
• Managed high-volume operations while maintaining accuracy, quality, and patient safety standards.
• Supervised pharmacy staff and ensured adherence to SOPs and best practices.

Master of Science - Pharmaceutical Sciences - University of the Philippines Manila (2025-08)

Bachelor of Science - Pharmacy - Our Lady of Fatima University (2018 - 2022)