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Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career. We have an exciting opportunity for a Manager, Qualified Person for Pharmacovigilance. This role can be remote based across multiple European locations.
Job Responsibility:
Prepare/maintain project-related documents
Compile the PSMFs (act as PSMF Coordinator) and ensure review/approval by the QPPV and timely submission to authorities, as needed
Quality check the PSMF prior to QPPV approval
Work on Pharmacovigilance projects for clients, based on experience and qualification
Includes negotiation of agreements, updates and terminations for all types of PVAs: SDEAs, PV Service Agreements, Quality Technical Agreements
Perform administrative tasks, as needed to support the QPPV and the PER PV GOV Practice Area
Act as Project lead (PL) for small projects (e.g. only QPPV/PSMF or PVA service in scope)
The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks in line with their abilities, qualification and training, if required
Requirements:
University degree in Life Sciences (preferred but not essential)
Several years' experience and profound knowledge in the field of pharmacovigilance (global PV systems)
Expertise, experience and knowledge of relevant legislative and non-legislative guidelines and requirements on pharmacovigilance
Proved ability in leading, mentoring, managing and motivation of staff (for project teams)
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Good communication skills (written and verbally)
ability to communicate issues and propose appropriate solutions to decision makers