REGULATORY, PHARMACOVIGILENCE AND MARKET ACCES SPECIALIST

Mandatory university degree in appropriate field: pharma, chemistry, biochemistry, medicine
At least 4 years of relevant experience in ︊︉︌︅︇︄️︋​︂︆︄︅​︁︁︎︌​︈︂︇︍​︈︆︅️︊︄︈︌︊︎︂︎Regulatory Affairs within the Pharmaceutical industry
Excellent knowledge and experience of working with NAMDM Romania
Knowledge of the National and EU regulatory framework
Languages: Professional use of the English language; both written and oral.

Personal qualifications:
Excellent interpersonal and communication skills
High ethical standards
Attention to detail
Strong organizational skills

REGULATORY
Consultancy on authorization of medicines through national, DCP or MRP procedures
Consultancy on post-authorization procedures (variations)
GMP, PhV and ︁︀​︂︃︃​︇︉​︄︀GDP Consultancy
Regulatory assessment for advertising campaigns/materials
Support activities:
Readability testing for Patient Information Leaflets
DTP – PILs, packaging
Specialized medical translations
Medical writing for marketing purposes
Trainings/ courses health product advertising conformity
Regulatory affairs for medical devices
Training in the field of medical devices: legislation, good distribution practice, advertising of MD

PHARMACOVIGILANCE
Data collection services for Pharmacovigilance activities:
Local medical literature screening (Romania)
Local medical scientific events monitoring;
24/7 call center system for AE reporting, quality complaints, providing medical information and medicines’ availability
QPPV - qualified person with certification
ICSR tracking, reconciliation, follow-up
Risk Management Plan
PSURs (periodic safety update reports)
SUSAR reporting
DSURs (Development Safety Update Report)
PhV Audit support
KPI report preparation
Reports Management Assessment

MARKET ACCES
Competition evaluation (pricing, reimbursement and HTA)
Submission of pricing applications
Monitoring of submitted applications
Review of Prescribing and Reimbursement Protocols
Ensuring communication between the company and authorities

Since 2014, MLD-V Limited SRL (part of the MLD Trading EOOD Bulgaria group) is present in Romania with a wide range of niche products from established partners, in the fields of: Obstetrics & Gynecology, IVF, Endocrinology, Dermatology, Urology.