PV Alliance Expert

Independently manage the process of creating, negotiating, concluding and archiving contracts with external partners regarding various aspects of pharmacovigilance (PV). In particular:

• Management of the process of concluding contracts (including SDEA and service agreements) and the fulfilment of obligations arising from contracts in PV
• Diagnosing the needs to conclude PV agreements in the organization (new  licensing projects, B2B, market research)
• Coordinating negotiations with external partners, managing the process of signing and archiving contracts, including ensuring the necessary input and opinions of internal stakeholders in the provisions of the PV agreement (in particular the PV and legal departments) guaranteeing the correctness of the provisions of the agreements and their compliance with the applicable regulations and policies of the company
• Tracking responsibility and control of the correct processing of PV information resulting from contracts in the areas of the company included in the process, especially the PV and In-licensing, B2B, QA departments.
• Creating standards in the area of PV contracts (contract templates, SOPs, instructions, summary reports) in accordance with applicable legal regulations and company policies and managing the resulting documentation.
• Preparing and conducting training in the field of PV contracts for relevant internal customers (in particular the PV department) and archiving training materials.
• Participation in external and internal audits in the field of PV contracts, enforcement of post-audit CAPAs.
• Maintaining existing standards and tools for monitoring the status and archiving of contracts, as well as their development and improvement, with particular emphasis on available AI solutions

• Higher education in law, pharmacy, economics, public relations or related.
• Minimum of 3-5 years of professional experience in the pharmaceutical industry in a position related to contracts negotiation/handling.
• Experience in the area of pharmacovigilance and knowledge of respective EU and international law/regulations will be an additional advantage.
• High negotiation and communication skills, focus on achieving goals.
• The ability to think analytically, analyze and regularly and reliably present data and the status of the processes carried out.
• Ability to identify problems, identify causes, and find solutions in a changing business environment. Business openness and goal orientation.
• Fluency in English (especially in business/pharmaceutical/legal aspects).
• Knowledge of MS Office.
• Ability to work in a team and organize work independently.
• High responsibility for the tasks entrusted to them.

• Employment contract
• Private healthcare
• Life insurance
• Multisport card
• Special occasion bonus
• Christmas packages for children
• One extra day off
• Retirement plan