Regulatory Specialist

Responsibilities

• Adverse Event Management: Managing adverse events (ADR) in compliance with AEM regulations and company policies, investigating statistical issues, and submitting reports.
• Database Management: Regularly updating and maintaining the database, submitting reports.
• Article Analysis: Monitoring changes in local scientific journals.
• Regulatory Changes Monitoring: Tracking changes in pharmaceutical regulations in Azerbaijan.
• International Pharmacovigilance Compliance: Ensuring compliance with international regulations such as FDA, EMA, ICH, WHO, and EAEU.
• Risk Assessment: Monitoring government safety reports and conducting risk assessments.
• Compliance with Standard Operating Procedures (SOPs): Adhering to established SOP guidelines.
• Pharmaceutical Data Analysis: Conducting regular statistical evaluations of pharmaceutical products.
• Participation in Medical Events: Representing the company at conferences, seminars, and business meetings.
• Training Participation: Learning and adapting to newly implemented systems.
• Drug Registration: Tracking pharmaceutical statistics and supporting the registration process.

Qualifications & Requirements

• Education Level: Bachelor's degree
• Work Experience: 1 year
• Technical Skills: Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Ability to work in a team
• Attention to detail
• Analytical thinking skills

Work Conditions

• Salary: Competitive
• Bonus Structure: Performance-based bonuses and annual incentives
• Benefits & Allowances: Coverage for meals, transportation, and sports expenses
• Additional Perks: Corporate phone, health insurance, and career development training

Please send your CV to  [email protected]  email address by ”Regulatory Specialist” the name of the vacancy.