Deskripsi Pekerjaan
We are looking for a dedicated and detail-oriented Senior Vigilance Reporting Associate (Medical Device) to join our team at The HIRD in Cebu City. In this critical role, you will be responsible for preparing accurate and compliant vigilance reports for medical devices, ensuring strict adherence to global regulatory standards and timelines.
This is an excellent opportunity for professionals seeking a career in the healthcare BPO sector. You will play a vital role in safeguarding patient safety by meticulously documenting, tracking, and analyzing adverse events and product complaints. You will collaborate closely with cross-functional teams to ensure data integrity and regulatory compliance in a fast-paced environment.
Tanggung Jawab
- Prepare, review, and submit high-quality vigilance reports for medical devices in line with FDA and international regulatory guidelines.
- Collect, verify, and process adverse event data from various sources, including complaints, literature, and clinical studies.
- Maintain vigilance databases and tracking systems to ensure accurate case management and timely closure.
- Coordinate with Medical Affairs, Quality Assurance, and clients to resolve case-related queries and ensure compliance.
- Generate Periodic Safety Update Reports (PSURs) and trend analysis for management review.
- Ensure all documentation meets Good Vigilance Practice (GVP) standards and internal quality checklists.
- Stay current with changing regulatory requirements and communicate updates to the team.
Kualifikasi
- Bachelor's degree in Nursing, Pharmacy, Biology, or other related Life Sciences.
- Prior experience (2+ years) in Pharmacovigilance, Medical Device Vigilance, or Regulatory Affairs.
- Solid understanding of global regulatory guidelines (e.g., GVP, 21 CFR Part 820, EU MDR).
- Proficiency in MS Office and experience with vigilance software (ARGUS, ARISg) is highly advantageous.
- Exceptional attention to detail, accuracy, and organizational skills.
- Strong analytical skills with the ability to interpret complex medical data.
- Excellent written and verbal communication skills in English.
- Experience in a BPO or call center environment is a plus.