Regulatory, Quality and Pharmacovigilance Junior Officer
Location: Nicosia
Phadisco Ltd
Phadisco is one of the leading pharmaceutical companies in Cyprus engaged in the exclusive distribution and sales of branded pharmaceuticals, food supplements, medical equipment, medical devices, diagnostics and infant milk formula.
ABOUT THE ROLE
We are seeking an academical qualified person to join our team as Regulatory, Quality and Pharmacovigilance Junior Officer. This is a position responsible for overseeing the company's pharmacovigilance system while simultaneously managing the regulatory affairs lifecycle for our product portfolio and help in maintaining the ISO systems of the company.
The successful candidate will ensure full compliance with EU and Cypriot legislation, act as the Deputy QPPV, and support the planning for new drug registrations and maintenance of existing Marketing Authorizations.
KEY RESPONSIBILITIES
A. Pharmacovigilance (Deputy QPPV Duties)
Assume the responsibilities of the QPPV in their absence and perform delegated tasks as required.
Support in maintaining oversight of the EudraVigilance database, ensuring electronic submission of all adverse event reports.
Support in maintaining the company’s pharmacovigilance system and ensure all procedures are followed.
Support the oversight of audits, PSUR quality, and the timely production and quality of the PSMF.
Participate in signal detection activities, benefit/risk evaluations, and labelling change decisions.
Receipt and documentation of AEs and ADRs.
Train and inform company employees on pharmacovigilance matters.
Represent the company during pharmacovigilance inspections (by authorities or partners).
Local literature review.
Keep up to date with changes to global and European pharmacovigilance legislation.
B. Regulatory Affairs
Supervise, plan, and coordinate the registration of new pharmaceutical products, food supplements & medical devices with the Ministry of Health.
Prepare and submit all relevant documentation for Marketing Authorizations (MAs) .
Oversee the documentation of registrations to ensure compliance with national legislation and proper submission methods.
Manage the timely submission of renewals and variations for existing licenses.
Liaise with the Medicines Regulatory Authority in Cyprus and abroad to resolve regulatory issues.
Oversee correspondence with the Medicines Authority and principals.
Ensure proper maintenance of all regulatory files and databases.
C. ISO MANAGEMENT
Support in maintaining the ISO systems.
Ensure proper adherence to ISO procedures.
Conduct internal audits and inspections at contracted distribution companies.
Receive and process product complaints and medical information enquiries from healthcare professionals and patients.
Prepare reconciliation reports.
Adhere to all company Health and Safety policies and procedures at all times, ensuring a safe and compliant working environment.
Ensure the proper use of any provided equipment, the immediate reporting of any hazards, incidents, or near misses to the relevant department, and active participation in any mandatory Health and Safety training sessions.
QUALIFICATIONS & REQUIREMENTS
Education: Degree in Pharmacy, biology, chemistry or other relevant field.
Languages: Excellent command of English and Greek (both written and verbal).
Competencies:
Strong leadership and organizational skills.
Ability to manage multiple projects and deadlines.
High level of integrity and attention to detail.
WHAT WE OFFER
Attractive Remuneration Pack
Πώς να υποβάλετε αίτηση
Interested candidates are invited to submit their CV and a cover letter to:
