Pharmacovigilance Agreement Manager

Purpose and Scope

This role is accountable for compilation, distribution and maintenance of all Richter Gedeon (Richter) Pharmacovigilance Agreements (PVAs) with licence partners to ensure compliance with regulatory requirements and with Richter's internal standards. You will be the main point of contact for Richter's business development and for Richter's global patient safety units within headquarters and is responsible to establish and maintain good business relations with Richter's business partners. Timely execution and implementation of PVA related tasks have a direct impact on the Company's compliance and may have impact on financial budget.

Essential Job Responsibilities:

• Represents the Global Patient Safety Team (GPS) in the negotiation, contractual management, and operational maintenance of Third-Party PVAs

• In collaboration with Global Pharmacovigilance functional lines, drive relevant planning, execution, and governance of PVAs in partnership with Legal

• Responsible for alignment with Business Development related to the overall delivery of quality licensing agreement deliverables and participation in due diligence efforts

• Contributes to PVA process improvement initiatives

• Independently assesses, writes, updates, maintains, and stores PVAs according to internal guidelines and Company policies and standards

• Independently organizes, conducts and/or facilitates meetings with business partners in the negotiation of PVAs

• Supports PVA and New Business Integration/Divestment process: Responsible for monitoring the Alliance contract and escalating as appropriate for contractual issues

• PVA development - own end-to-end process of development, execution, maintenance, and termination (when applicable) of PVAs and associated deliverables. May include strategy setting, with input, as necessary, from line management

• Ensure accurate information is maintained in the tracking tools for PVAs

• Sets tactical approaches and drive more effective operational plans for PVA negotiation and execution

• Maintains the internal guidelines for creating, updating and retention of business partner related PVAs

• Manage relationships with business partners

• Escalate issues appropriately

What You’ll Bring

• BA/MS degree with 1+ years’ experience in the pharmaceutical industry in Pharmacovigilance/Regulatory.

• Able to chair meetings, present orally in English and interact with business partners.

• Knowledge of GVP modules

• Advantage: Experience in contracting and negotiation with partners.

Other information

• The position is fixed-term ( appr. 2 years)

We offer

You can work in a team of helpful colleagues, where we value supportive collaboration and thinking together. In addition, we offer
•    Challenging, responsible professional work
•    Opportunity for continuous development
•    Long-term employment in an innovative and secure workplace
•    Training and development opportunities
•    Medical services and life insurance
•    Various sport and health opportunities
•    Extensive benefits package