PV and Compliance Specialist

•  Act as a Person responsible for Pharmacovigilance (PRPV) and Vigilance (PRV) at Medicines and Medical Devices Agency of the Republic of Serbia
• Ensure the company's PV responsibilities and safety data reporting procedures are fully met with regards to the pharmacovigilance quality management system and national legislation
• Responsible for compliance at the local level, that is acting as Local Compliance Officer
• Implement, maintain and comply with local Pharmacovigilance and Compliance documents in accordance with Group Procedures and local legislation
• Ensure the company’s activities comply with the business partners agreements and/or regulatory obligations, specific to Pharmacovigilance and Compliance
• Manage the preparation and follow-up of any internal or external audits and/or regulatory inspections impacting Pharmacovigilance and Compliance from announcement until closure
• Create local standard operating procedures and conduct training and continuous education of employees in the fields of Pharmacovigilance/Vigilance and Compliance
• Act as a deputy of a Person responsible for documentation at Medicines and Medical Devices Agency of the Republic of Serbia
• Support processes related to regulatory activities for various company products (medical devices, cosmetics and food supplements)
• Participate in creating and approving of promotional and nonpromotial materials