PERSONAL INFORMATION
Nejazi Bajrami

Rr.Tirana K IV N#3, 70000 Ferizaj (Kosovo)

+38349651553 : +383445503581

+38338542227
[email protected]

JOB APPLIED FOR
Regulatory Affairs Manager
WORK EXPERIENCE

1 Mar 2016–Present
Regulatory Affairs and Pharmacovigilance Manager
KEIS PHARMACEUTICALS, PRISHTINE (Kosovo)
Regulatory: Process mapping,dossier preparations for new product applications,renewals,variations assessment, variations applications,labelling,artworks and follow up,translation of documents in to local languages,monthly reports to MAH including event reports as per Article 23 EU Directive requirements,etc.

Pharmacovigilance: Establish PV System creating quality document with SOP,training QP Deputy Pharmacist and company staff for SOP implementation and compliance, collection of ADR, submission of PSUR a to Kosovo Medicines Agency according to national legislation.

Serving for: Sanofi Pasteur-France, biologics (vaccines) and

Besins Healthcare-Belgium, small molecules.

1 Jan 2015–1 Mar 2016
Regulatory Affairs and PV Officer
Galeni Group Sh.p.k., Viti (Kosovo)
First time registration of ZAMBON products with Kosovo Medicines Agency, acted as 24 hours single contact person according to local legislation.

1/1/2013–31/12/2014
Medical Representative
FARMITALIA Sh.p.k., Prishtine (Kosovo)
Market research,meetings with Physicians and Community Pharmacists, product presentation, involved in pharmacovigilance activities for signal detection,case assessment etc.

11 Jan 2003–2 Dec 2012
Responsible Pharmacist
Pharmaton Pharmacy, Ferizaj (Kosovo)
Patient consulting,oversee technical team,work schedules,orders, inventory,compounding,prescription processing,check drug-drug interactions, drug-disease incompatibility etc. ​

EDUCATION AND TRAINING

Oct 2010–Dec 2012
Diploma in Medicines Development Sciences

Free University of Brussels, Brussels (Belgium)
Pharmaceutical Medicine​ PHARMED Program.

Oct 1992–Jul 1997
MPharm

University of Tirana, Tirana (Albania)

Sep 2013–Dec 2013
Certificated in Pharmacovigilance and Regulatory Affairs,Medicines Benefit Assessment and Medicines and Public Health

EU2P Consortium-Universite de Segalen, Bordeoux (France)

Jun 2013–Mar 2014
Professional Certificate in Pharmacovigilance

Catalyst Clinical Services Pvt.Ltd., Delhi (India)

PERSONAL SKILLS

Mother tongue(s)
Albanian

Other language(s)
UNDERSTANDING
SPEAKING
WRITING
Listening
Reading
Spoken interaction
Spoken production

English
C1
C1
C1
C1
C1
Croatian
C1
C1
C1
C1
C1
German
B1
B1
B1
B1
B1

Levels: A1 and A2: Basic user – B1 and B2: Independent user – C1 and C2: Proficient user

Common European Framework of Reference for Languages

Communication skills
Good communication skills gained  through experience and abroad.​

Organisational / managerial skills
Can manage small teams​ with consistency and  being polite.

Job-related skills
Ability to work under pressure.​

P.S.

-Have worked in projects with Kosovo Medicines Agency as an extern expert for drafting new regulatory guidelines for medical devices during September,October 2016.

-Assembly Member of Kosova Chamber of Pharmacists.

-Pharmatrain Federation,Brussels-Individual member since 2018.
Digital skills
SELF-ASSESSMENT
Information processing
Communication
Content creation
Safety
Problem solving

Independent user
Proficient user
Independent user
Independent user
Independent user