Medical Advisor, Regulatory Affairs & Pharmacovigilance Specialist/ Junior Specialist

Main Responsibilities:

• Responsible for Medical Information Management and validation of the medical information requests and tracking
• Provide in country Medical affairs support for assigned portfolio of medicines
• Manage and supply Medical information to internal and external customers
• Review and approval of promotional and non-promotional materials comply with relevant laws, regulations, Bausch Health policies and procedures, industry codes and ensure that are medically and factually accurate and properly referenced and supported
• Develop and maintain on regular basis close relationship with relevant external business partners (medical societies, KOLs, etc.)
• Pharmacovigilance activities: Intake and forwarding of Adverse Events to Global Pharmacovigilance & Risk Management (GPRM) or partner (as applicable);; reconciliation activities and documentation of AEs; acting as back-up of local PV contact person
• Regulatory activities - Preparation and updating of local SmPC/ PIL/labelling; handling Safety variation; upload relevant documentation in company electronic systems and keep up to date company database; making appointments, organizing and preparing all required documentation for timely submissions for new products, renewals, and variations for products

Requirements:

• University Degree – Pharmacy or Medicine (human, dental or veterinary)
• Influencing communication and presentation skills
• Fast learner with high level of adaptability
• Ability to work under minimum supervision
• Excellent English language knowledge
• Hands-on experience with MS Office (Word, Excel and PowerPoint). Database experience will be considered as an advantage
• Previous experience in drug registration and pharma regulations would be a significant advantage

The company offers:

• Opportunity to work in a multinational organization providing innovative and high-quality products which have impact on people’s lives
• Learning and development opportunities
• Friendly and supportive team atmosphere
• Stable, secure and dynamic work environment
• Attractive compensation & additional social benefits
• Strict and fair employment policies

To apply, send your CV in English via Jobs.bg - https://www.jobs.bg/job/4549227