Regulatory Affairs & Pharmacovigilance Officer
Pharmaceutical
Permanent
Zebbug, Malta
Job Description
Are you a registered pharmacist, with previous experience?
If your answer is yes, then this might be the ideal opportunity for you!
GCS Malta is looking to hire a Regulatory Affairs & Pharmacovigilance Officer for one of Malta's top distribution companies.
The ideal candidate should be a registered pharmacist, preferably in Malta. At least 3 years of experience in regulatory affairs, pharmacovigilance and/or medical device vigilance is considered an asset.
The role requires solid knowledge of EU and Maltese regulatory requirements, along with a strong work ethic and a proactive attitude. The ideal candidate should be able to work independently while effectively collaborating with cross-functional teams, demonstrating strong organisational and prioritisation skills as well as excellent written and verbal communication abilities.
What are you waiting for?
If your answer is yes, then this might be the ideal opportunity for you!
GCS Malta is looking to hire a Regulatory Affairs & Pharmacovigilance Officer for one of Malta's top distribution companies.
Responsibilities
- Ensuring compliance with Malta Medicines Act, EU Directive 2001/83/EC, and GDP requirements
- Preparing and maintaining documentation for authorisations, renewals, variations, and notifications
- Liaising with authorities on submissions, approvals, and pharmacovigilance matters
- Supporting distribution operations with accurate regulatory documentation and product classification
- Monitoring regulatory updates and assessing impact on product portfolio
- Assisting in audits, supplier qualifications, and maintaining the Quality Management System
- Supporting Regulatory Affairs and Pharma Tenders Manager across export markets
- Performing local Pharmacovigilance (PV) duties, including adverse event and product complaint reporting
- Maintaining PV records, training logs, and assisting in PV/MDV inspections or audits
- Carrying out additional tasks as assigned
The ideal candidate should be a registered pharmacist, preferably in Malta. At least 3 years of experience in regulatory affairs, pharmacovigilance and/or medical device vigilance is considered an asset.
The role requires solid knowledge of EU and Maltese regulatory requirements, along with a strong work ethic and a proactive attitude. The ideal candidate should be able to work independently while effectively collaborating with cross-functional teams, demonstrating strong organisational and prioritisation skills as well as excellent written and verbal communication abilities.
What are you waiting for?