PV and Compliance Specialist

Short Description

On behalf of our client, Ewopharma, Manpower Serbia is searching for a motivated candidate to take the challenge and to successfully fulfill the position of PV and Compliance Specialist

Description

•  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

Requirements

• Successfully completed studies (Pharmacy, Medicine, or Dentistry)
• Minimum 3 years of experience in a similar position
• PC skills - word, excel, power point
• Fluency in English (verbal and written)
• Effective Training and presentation skills
• Strong organizational skills with the ability to meet strict deadlines
• Demonstrates a positive and flexible working attitude
• Excellent verbal and written communication skills
• Ability to work effectively on multiple projects simultaneously and effectively manage competing
• priorities, excellent time management
• Sense for accuracy, urgency and document management
• High level of motivation
• Ability to complete individual goals and work in a team environment