Pharmacovigilance Project Manager, Client Services

ProPharma•Raleigh, NC

2d•Hybrid

About The Position

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.

Requirements

Professional and diligent demeanor.
Ability to liaise with (Associate) Director and management group members on issues.
Lead and manage long-term client-facing projects.
Manage project timelines.
Risk tracking.
Change control processes.
Cross-functional collaboration for operational efficiency.
Planning, communication, and execution of pharmacovigilance project deliverables in a global environment.
Lead day-to-day client interactions.
Oversee project plans, timelines, deliverables, scope, and quality.
Present at audits (assigned clients and internal PV audits).
Translate client needs into project processes.
Initiate Change Controls and Change management processes.
Monitor and communicate Key Performance Indicators.
Ensure financial performance targets are met.
Identify points of escalation.
Serve as the main point of contact for the assigned project team.
Ensure 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.
Prepare meeting agendas and minutes.
Communicate and manage action items.
Collaborate with cross-functional teams to ensure compliance with safety regulations.
Perform financial management tasks and monitor budget health (revenue recognition, forecasting, invoicing, budget reviews).
Develop and demonstrate excellent working relationships with clients and internal customers.
Support the Client Services organization in the Business Development process.
Ensure continuous identification and implementation of best practices and efficiencies.
Maintain awareness of company processes and industry regulations.
Actively participate in strategic planning.
Assist with overall oversight of the business.
Help establish and safeguard the culture.
Maintain personnel utilization.

Responsibilities

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.