Pharmacovigilance Specialist

The position directly reports to the Team lead of the unit, engages in the technical activities performed within the primary Unit and works also cross-functional, providing assistance and support with technical activities to other units within the PV department. PV specialist executes project related tasks and activities and is able to delegate activities to other team members within the unit (PV associate, PV assistant) as and if required, and ensures a high quality of the services provided.

What will be your key responsibilities:

  • 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

What experience should you have:

  • 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

What do you get in return:

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
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