Manager, Regulatory and PV Delivery

About the role

PrimeVigilance, a global pharmacovigilance specialist, is hiring a Manager, Regulatory and PV Delivery in London. The manager develops the strategy based on regulatory requirements and drives regulatory and PV deliverables according to an established PV and regulatory plan. The role also supports senior management in securing new business and provides strategic regulatory guidance, training, coaching and mentoring to junior staff.

Key responsibilities

• Lead and coordinate complex projects and deliverables, ensuring compliance with procedures, trackers and templates and meeting targets
• Give strategic input to internal and external customers, identify risks early and resolve performance or delivery issues
• Advise clients on complex queries and changes in local regulations and guidance
• Monitor project budgets and hours, and escalate out-of-scope work
• Take part in BDMs, develop and review regulatory sections of proposals, and prepare client invoices and approve vendor invoices
• Train, coach and mentor junior staff and support client qualification activities
• Ensure audit readiness, represent the department in audits and inspections, and follow up findings
• Contribute to the Regulatory Newsletter, maintain the regulatory database, collect and review regulatory intelligence and support interpretation of legislation
• Foster professional relationships internally and externally and drive departmental change initiatives

Required profile

• Minimum 3 years in the pharmaceutical or CRO industry or a regulatory body, including at least 3 years in a leading or project-management role
• Proven ability to manage global projects
• Ability to line manage members of staff

Required skills

• Expert knowledge of ICH GCP and/or GVP
• Knowledge of the most relevant legislation and local requirements for the territories of competency