Pharmacovigilance Specialist

• Work on projects and tasks assigned by the unit team lead
• Organize meetings with project members as required
• Ensure the delivery of projects/tasks in accordance with client needs as per the contractual agreements and procedures in place;
• Follow and achieve agreed personal KPIs and KPIs of the department
• Act as a process owner for assigned PV processes
• Provide training to project team members and other PV department employees on technical areas as needed
• Participate on trainings, both internal and external as required
• Improve teamwork collaboration by sharing best practices
• Constantly seek for and take into consideration the client and internal feedback to improve the efficiency and quality of work within the assigned projects
• Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication, ensuring full compliance with the processes and project deliverables
• Ensure that all CAPAs related to assigned projects and tasks are managed within the timelines
• Work cross-functionally and in collaboration with key stakeholders/customers, both internal (e.g., Commercial, Technical, Quality, Regulatory, Pharmacovigilance, etc.) and external (e.g., Competent Authorities, Clients, External Vendors, etc.)
• Participate in business meetings, bid defences with current and potential clients, as and if required
• Participate in audits and inspections, as and if required
• Participate in company marketing and promotional activities, as and if required
• Organise and file the document according to the company’s document management system
• Use company’s databases, systems and any other IT tools applicable for the job in line with company procedures
• Adhere to company’s processes and systems

• Bachelor’s degree or graduate in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences – advance degree (e.g. masters) preferable
• Minimum of 1 years of experience working in a medical or safety department with demonstrable expert knowledge of medical terminology
• knowledge of EU FDA submissions requirements and experience in case processing
• detailed knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.)
• experience working with a safety database desirable
• fluent verbal and written English
• ability to delegate and oversee work of junior staff
• ability to provide training to junior staff
• excellent team player, able to build an effective team
• organizational and time-management skills, able to prioritize work and adhere to deadlines
• excellent communication skills
• maintains a positive, result oriented work environment

Hybrid or remote working (Use of our offices in various locations, co-sharing work space or remote options available)
5 weeks holiday plus national holidays in your given location
3 personal days
Flexible benefits, based on location
Home office stipend
Annual bonus program
Other employee Bonuses (spot bonuses and employee nominated bonuses)
Dog friendly offices