Slovak Pharmacovigilance (PV) Lead

Position Overview Basic Functions And Responsibilities

 As PV Lead you will be responsible for ensuring compliance with PV processes and regulations, compliance with company policies and procedures, for establishing and maintaining best practices, and for representing the company for any product safety issues.

The PV Lead is the primary point of contact for the local Health Authority and serves as the local Qualified Person for PV (QPPV) / Local PV Contact for Czech Republic and Slovakia and ensures a back-up as required per local PV legislation.

You would also be responsible for interfacing with PV Headquarters and other functional areas, e.g., Regulatory Affairs, Clinical Research, Medical Affairs, Commercial functions, and other business unit colleagues in Czech Republic and Slovakia to ensure alignment on matters impacting PV.

The role includes the following activities:

• Overseeing and managing the day-to-day activities of the Pharmacovigilance Department at    Our Company in Czech covering Czech Republic&Slovakia. E.g., ensuring all local initiatives (e.g., digital interfaces, marketing initiatives, patient programs, organized data collection systems), as applicable, comply with PV requirements.
• Strategic leadership of the PV short and long-term country objectives including department structure/function/processes, PV Intelligence. Development and performance management of the members of the team in Czech Republic
• Serving as the local QPPV / Local PV Contact and complying with all requirements mentioned in the local laws and regulations. Ensuring a backup as required per local PV legislation.
• Audit / inspection readiness; coordination, leading, and active participation in local audits and inspections. Compliance activities and the preparation of necessary documents (e.g., Non-Compliance Investigation Reports, etc.) locally for late reports and deviations from internal policies and procedures; recommendations for corrective and preventive actions (CAPA), tracks CAPA commitments to address findings/observations and monitors until closure
• Shaping and development of local standards and procedures (in compliance with regional and global standards), to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
• Be recognized as a subject matter expert and driver of innovation in PV processes, pathways, and compliance and be considered a thought leader both externally and internally, increasing the company’s credibility in the pharmaceutical sector.
• The position reports to the PV CEE Cluster Lead. As requested, the PV Lead may undertake additional activities. Travel within the cluster, regionally, and globally is required.

Background Requirements And Qualifications

• You must have a health, life science, or medical science degree or equivalent by education/experience and be fluent in English (written and spoken) while being proficient in Slovak language.
• You should have at least 5 years of experience in the pharmaceutical industry with a specific focus on safety and pharmacovigilance related activities and supervisory experience of managing people/teams/contractors
• Experience collaborating across countries is preferred.
• The PV Lead is required to have strong leadership, communication, decision making, and problem-solving skills
• The incumbent must also have detailed knowledge of AE reporting requirements, relevant PV regulations and PV quality management systems as well as experience with PV audits and/or PV Health Authority Inspections
• Excellent interpersonal communications, organizational, and presentation skills as well as excellent negotiation and influencing skills are required
• Ability to work in partnership with others (internally and externally) to accomplish quality goals is expected