Company Description

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

---

Job Description

Role Overview

The Manager, Regulatory and PV Delivery is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They actively assist senior management in securing new business by participating in BDMs and contributing to proposals/budgets. They also provide strategic regulatory guidance, training, coaching, and mentoring to junior members; may be required to line manage members of staff.

Main Responsibilities

• Assume leadership and functional representation for projects and/or deliverables of high complexity ensuring effective and rapid coordination and management and execution of regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers, and templates.
• Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures.
• Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance.
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted, and promptly identify and escalate any OoS.
• Assist in securing new business or repeated business by participating in BDMs, developing, and reviewing regulatory sections of proposals, regulatory costing, and budgets.
• Prepare client’s invoices and review/approve vendor’s project invoices.
• Provide training, coaching, and mentoring to junior members of staff.
• Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow-up questions.
• Prepare and/or contribute to the Regulatory Newsletter and update the regulatory database when new information is available.
• Ensure collection, QC review, and timely dissemination of all regulatory intelligence related to departmental deliverables. Support interpretation and impact analysis on legislation.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Drive department/company initiatives, act as a change champion, and successfully manage implementation of the changes (communication, timing, and implementation plan).