Associate Pharmacovigilance Project Director (Delivery) - Europe

About the role

Ergomed is recruiting an Associate Pharmacovigilance Project Director (Delivery) for its Europe business. The role ensures that all contracted activities for PrimeVigilance clients are delivered within budget, on time, with good quality and in compliance with regulatory requirements. It is a full-time position based in Madrid.

Key responsibilities

• Support project teams as a PV expert on all contracted activities and advise the client on PV matters such as changes in regulations and guidance.
• Support the Head of PM department, the Head of PV Operations and senior leadership, and represent the client's and PrimeVigilance interests with the client.
• Oversee changes to project scope, schedule and costs, and monitor project set-up and maintenance activities.
• Maintain good client relations, attend client meetings, review client-specific core documents (e.g. joint operational guidelines, safety management plan) and prepare and send invoices on time.
• Oversee Quality Management System activities, ensure quality standards are met, and ensure compliance with worldwide PV regulatory obligations.
• Manage the Quality Events process and implement corrective and preventative actions (CAPA).
• Take part in client audits and inspections, and provide the client with qualified resources and project analysis as needed.
• Train project teams and cooperate closely with other PrimeVigilance and client departments.

Required profile

• Varied PV experience in a CRO.
• Previous experience in PV project management.
• Excellent written and verbal client-facing and internal communication skills.
• Leadership, coaching and team-working abilities, with conflict resolution and decision-making skills.