Pharmacovigilance Officer

Description:

At 5G Healthcare, we are a medical device manufacturing company committed to innovation, safety, and regulatory compliance. We develop high-quality medical devices that meet both national and international standards—contributing to better patient care and healthcare delivery.

We are currently looking for a Regulatory Affairs & Pharmacovigilance Officer to join our Regulatory team and help ensure that our products meet all legal and safety requirements from development to post-market surveillance.

Responsibilities

• Prepare, compile, and submit regulatory documents, including CTD dossiers, for product registration and renewals
• Communicate with local regulatory bodies to ensure timely approvals and responses
• Monitor and report product safety issues in line with pharmacovigilance requirements
• Maintain accurate regulatory records and documentation
• Stay updated on relevant regulations and ensure internal compliance
• Support regulatory inspections (e.g., DRAP audits) and respond to queries effectively
• Work closely with QA, Production, and R&D teams to ensure regulatory alignment

Requirements

• Education: Pharm-D
• Experience: 2–3 years in regulatory affairs and pharmacovigilance, ideally in the medical device or pharmaceutical industry
• Familiarity with regulatory procedures, dossier formats (especially CTD), and pharmacovigilance systems
• Proficiency in MS Office
• Strong written and verbal communication skills