Job Title: Regulatory & Pharmacovigilance Specialist

Description:
Trimed represents a safe and measurable way to provide unadulterated pharmaceutical product to the Albanian market with direct access to pharmacies. Trimed management encompasses both local and international expertise in the tracking, marketing and distribution of pharmaceuticals. Trimed is dedicated in “setting the standards” for pharmaceutical product distribution and thereby patient safety in the Albanian market.

Responsibilities:

Communication with the NAMMD regarding any request, deficiency, update and respond on the requests, deficiency letters as per required timelines by NAMMD;
Monitoring and information in writing of any changes in the legislative requirements, new regulations, trends in assessment of the dossier by NAMMD;
Maintenance of the portfolio and its compliance by submitting on time renewals and variations once receiving complete documentation and ensuring business continuity;
Checking, control and approve of packaging materials to ensure regulatory compliance;
Archiving all documentation necessary for the registration as well as correspondence and any other written documents;
Operating in a dynamic and international regulatory team;
Contact point with authorities on pharmacovigilance activities;
Oversee and coordinate adverse event (AE) reporting process including an internal escalation process for serious unexpected AEs and quality issues associated with AEs;
Review promotional materials and Food Supplement stickers as per the approved labelling, applicable guidelines and local regulations, and within the required timeframe;

Qualifications:

Field of study: Pharmacy; Biotechnology; Chemistry;
Fluent in English;
Preferred with previous similar work experience;

Notes: