Deskripsi Pekerjaan
Nezda Technologies is currently seeking a detail-oriented Vigilance Reporting Associate (Medical) to join our growing team. This is an excellent opportunity for professionals looking to advance their career in the pharmaceutical or life sciences industry. In this role, you will play a critical part in ensuring patient safety by managing and analyzing safety data. This is a Virtual Hiring Process, meaning you can work from the comfort of your home, specifically in Cebu City, Cebu.
As a Vigilance Reporting Associate, you will be responsible for the end-to-end process of safety reporting. Your expertise will ensure that all adverse events are captured accurately and reported to relevant regulatory bodies in compliance with global standards. We pride ourselves on a culture of continuous learning and support, providing you with the tools you need to succeed in a fast-paced environment.
Tanggung Jawab
- Monitor and evaluate safety information from various sources, including medicinal product information, literature, and spontaneous reports.
- Perform comprehensive medical review of suspected adverse drug reactions (ADRs) to ensure accuracy and completeness.
- Accurately code and document safety data using industry-standard terminology and databases.
- Compile and format safety information for submission to regulatory authorities or internal pharmacovigilance systems.
- Conduct literature searches and data retrieval to support medical queries and safety assessments.
- Ensure strict adherence to global pharmacovigilance regulations and internal company policies.
- Participate in internal safety meetings and training programs to stay updated on industry best practices.
Kualifikasi
- Bachelor's degree in Pharmacy, Nursing, Medicine, or a related Life Science field.
- Strong understanding of pharmacovigilance principles and regulatory guidelines (e.g., ICH-GCP, ICH-E2B).
- Excellent written and verbal communication skills in English.
- Proficiency in computer applications, including MS Office and database management tools.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to work independently and collaboratively in a remote/virtual setting.
- Experience in a medical or clinical setting is a strong plus.