Who are we?
We Are PRA Health Sciences. We provide innovative drug development solutions across all phases and therapeutic areas. But innovation just for the sake of innovation isn’t why we do it. Side by side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every day. It’s who we are. Innovating to help people is at the heart of our process, but it’s even more than that. It’s our privilege.
We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives, and we are constantly striving to be the best at what we do.
What will you be doing?
In Pharmacovigilance & Patient Safety, the Safety Project Manager (SPM) is responsible for owning and achieving successful interim and final contractual deliverables on assigned global, PVS Stand Alone projects/programs, according to the time, quality, scope and cost constraints. The SPM leads and directs cross-functional teams, understands and manages client expectations/needs to achieve client satisfaction. The SPM proactively identifies, escalates, resolves/mitigates, risks and/or issues. The SPM adheres to PRA standard procedures and processes. The SPM serves as a PVS representative during the business development process.
- Acts as primary liaison with client:
- Acts as lead contact for regional and or/project matters.
- Understands/manages/satisfies client contractual, organizational and relationship needs/expectations.
- Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client.
- Chairs and leads client meetings.
- Leads and directs cross-functional team leaders and third parties/vendors with some supervision and support:
- Contributes to development, maintenance and approval of project plans. Guides and supports team leads in prioritizing, trouble-shooting and contingency planning.
- Delegates whilst retaining ownership.
- Communicates project specific priorities.
- Liaises with functional leads/managers to optimize performance and utilization of project team members.
- Manages project contractual deliverables:
- Supervises progress via metrics.
- Monitors and ensures adherence to the contractual agreement (time, quality/scope, and cost deliverables).
- Leads presentation of internal project status reviews and is accountable for action item follow up.
- Proactively identifies, resolves/mitigates and escalates risks and/or issues.
- Manages project costs:
- Owns projections of units/hours (revenue and resources), actual units/hours efficiency analysis.
- Proactively and timely identifies, for assigned projects, ensuring out of scope activities are approved upfront via a contract modification.
- Identifies potential or actual unrecoverable hours and provides analysis and mitigation/resolution plan for senior management’s approval.
- Ensures control of financial risk to PRA.
- In cooperation with the project analyst, applies efficient management of project pass-through costs and investigators payments to ensure all such costs are recovered in a timely manner, and in advance where ever possible.
- Leads presentation of financial reviews and is accountable for action item follow up.
- Ensures adherence to company SOP, policies and guidelines at the project level.
- Assumes project leadership role in compliance at project level to PRA processes and systems including escalation to relevant functional and operational management.
- Participation and attendance in bid defense process.
- Provides feedback on project team member’s performance to respective line-managers.
Location: Depending on level of experience this can be a remote based position in Western Europe.
What do you need to have?
In addition to this experience, we are looking for candidates who are excited by new and evolving technology and who want to work in a dynamic team where timely and proactive communication is critical to success.
- substantial pharmaceutical or contract research organization background
- 3 years experience in pharmacovigilance and patient safety
- 1-2 years functional management and project leadership experience
- knowledge of relevant ICH statistical analysis and report writing as well as regulatory submission requirements guidelines for human drugs in NA and Europe
- life sciences degree
- fluency in English
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.