For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
The Pharmacovigilance (PV) Project Manager will be expected to be professional and diligent and shall liaise with the (Associate) Director and management group members in the team on any issues. They will lead and manage long term engagements in client-facing projects to include but not limited to managing project timelines, risk tracking, change control processes and cross- functional collaboration to ensure operational efficiency. The position focuses on planning, communication, and execution of pharmacovigilance project deliverables in a global environment.
Essential Functions:
Implementing and overseeing client Pharmacovigilance projects.
Lead day-to-day client interactions and oversee project plans, timelines, deliverables, scope and quality.
Present at audits for assigned clients and internal PV audits.
Effectively translate clients’ needs into project processes.
Initiation of Change Controls and Change management processes.
Monitor and communicate Key Performance Indicators and ensure financial performance targets are met.
Appropriately identify points of escalation.
Main point of contact for the assigned project team ensuring:
Training and compliance on project processes.
Disseminate expectations and information from the client.
Lead internal and external meetings to update project status, discuss strategies and ensure alignment with objectives, including
Preparation of agenda and minutes.
Communicate and manage action items.
Collaborating with cross-functional teams to ensure compliance with safety regulations.
Perform financial management tasks and monitor budget health, including revenue recognition, forecasting, invoicing, and budget reviews.
Develop and demonstrate excellent working relationships with clients and internal customers.
Support the Client Services organization in the appropriate phases of the Business Development process.
Ensure continuous identification and implementation of best practices and efficiencies to support the evolution of services.
Maintain awareness of company processes and industry regulations.
Actively participate in the strategic planning process, assist with overall oversight of the business, and help establish and safeguard the culture.
Maintain personnel utilization as a part of the objectives of this role.
Other duties as assigned.
Necessary Skills & Abilities:
Understanding of ICH-GCP, FDA, EMA, and other relevant global regulations related to PV.
Excellent organizational and project management skills, with the ability to manage multiple projects and priorities.
Ability to anticipate issues and develop and offer solutions to minimize disruptions.
Interacting with appropriate client personnel to resolve issues related to assigned projects.
Excellent attention to detail and focus on quality.
Awareness of global culture and willingness to work in a matrix environment.
Computer proficiency, IT skills, expertise and ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/ PowerPoint).
Educational & Experience Requirements:
Life Sciences Degree or equivalent.
Minimum of 6+ years' experience and track record of success in project management.
4+ years' experience in Pharmacovigilance and/or Clinical Development.
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#LI-REMOTE
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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