Pharmacovigilance Officer

About the job

Position: Regulatory Affairs & Pharmacovigilance Officer

About Us

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

Benefits

• Paid time off including vacation, sick, and emergency leaves
• Health insurance (post-confirmation)
• Reward and recognition programs
• Supportive and flexible work environment

📧 Apply Now: Send your resume to [email protected] Or WhatsApp us at 0341-5553371

Benefits found in job post

• Medical insurance