Project Manager - Pharmacovigilance

United Biosource Corporation; United States; À distance; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Remote opportunities

401K with company match

Discretionary PTO

Paid Holidays

Medical, Dental, and vision coverage

Wellness program

Life insurance

Employee assistance programs

Résumé du poste

United Biosource Corporation is seeking a Project Manager - Pharmacovigilance to lead PV project teams, delivering contracted milestones and ensuring on-time, on-budget delivery across multiple programs. The role covers start-up through close-out with client-facing responsibilities and cross-functional collaboration.

You will manage budgets, timelines, and project communications, prepare PM plans, dashboards, and KPI reports, and support PV leadership.

Qualifications

• Bachelor’s degree or equivalent experience.
• Minimum of 2 year direct project management experience at a CRO or pharmaceutical company and/or 4 years of pharmacovigilance experience or equivalent experience.
• Knowledge of global and local PV regulations and legislation, both pre- and post-marketing, preferred.
• Strong project management, interpersonal, verbal and written communication skills, both internally and towards clients.
• Ability to identify, document, track and resolve project action items for multiple programs simultaneously.
• Ability to create, review and revise documentation, processes and procedures as they relate to PV activities, to identify issues/problem areas, assess compliance, and communicates findings to the appropriate team(s) and management.
• Experience with Argus or other industry standard safety database(s)
• Project financial expertise including invoicing, revenue recognition, margin analysis, scope management and resource management.
• Demonstrated supervisory skills preferred.
• Demonstrated independent problem solving and issue resolution track record.
• Excellent interpersonal and client management skills.
• Must be flexible and adaptable to quickly changing project priorities
• Must be able to speak fluent English.
• Ability to travel to UBC locations, clients, and professional/scientific meetings.

Responsabilités

• Manages Pharmacovigilance project(s) as assigned by PV Management per the scope of work and within the contracted budget and timelines.
• Responsible for the overall on time, on-budget delivery of the contracted Scope of Work for assigned projects.
• Oversees all aspects of the PV project conduct from Start-up through Close-Out.
• Serves as UBC primary contact with the client.
• Ensures appropriate project related communication within the project team.
• Leads and coordinates internal project and client teleconferences/meetings.
• Prepares project timelines and project management related deliverables.
• Identity, document, track and resolve project action items for multiple programs simultaneously
• Establishes and manages project communication tools (e.g. project email address, project specific teleconference number, project portal/SharePoint).
• Coordinates development of Project Specific plans to achieve contracted milestones (i.e., Adverse Event Reporting Plan, Periodic Safety reporting Plan).
• Prepares and maintains Project Management Plan.
• Ensures project is conducted in concert with SOPs and client’s SOPs and, in accordance to the highest quality standards.
• Prepares and keeps the Project team log and project specific training matrix up-to-date.
• Ensures project specific trainings are assigned to relevant project team member as per project specific training matrix.
• Maintains and files project specific training records for the project team.
• Prepares project metrics & KPI and monthly metrics reports, as needed.
• Supports Qualified Person Responsible for Pharmacovigilance in Europe (EU QPPV) and local QPPV(s) in his/her activities throughout the project.
• Prepares project specific presentations for client meetings/audits.
• Assists in project specific audit/inspection preparation and actively participate in the audit/inspection.
• Develops and implements CAPAs related to Project Management issues as necessary.
• Ensures that project specific CAPAs/SIRs are being closed on time.
• Tracks non-compliance issues in frame of his/her projects.
• Escalates issues in a timely manner to the PV Director /Associate Director who supervises the project.
• Maintains cumulative list of Actions items for the project including owner, due date, status, etc…
• Reviews contract and project scope to ensure that change orders (CO) are issued as necessary.
• Works with contracts team on CO development and execution.
• Performs project financial oversight (identify percent complete units for monthly revenue recognition meeting with Finance as well as forecast future unit completion).
• Ensure project budget is tracked against contract milestones.
• Oversees project profitability analysis and present findings as requested to Senior PV Management.
• Supports business development initiatives including proposal, slides, attendance at bid defense meetings and proposal and budget development.
• Determines the need for third party vendor services and coordinate vendor management activities
• Other duties as assigned by Senior Management.

Connaissances

Project management

Client management

Communication skills

Pharmacovigilance knowledge

Regulatory knowledge

Budgeting

Leadership

Formation

Bachelor's degree

Outils

Argus

SharePoint

MS Excel

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Project Manager - Pharmacovigilance

US-Fixed Term Research & Clinical All Virtual Locations, Home Based Position, USA, Remote, US

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improvingpatient outcomes and advancing healthcare.At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impacton the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

****This opportunity is for a 6 month Fixed Term Contract****

Job Title :

Brief Description :

Responsible for leading UBC Pharmacovigilance (PV) project teams to deliver contracted services and ensuring achievement of contracted project milestones for assigned projects.

Requirements :

• Bachelor’s degree or equivalent experience.
• Minimum of 2 year direct project management experience at a Contract Research Organization (CRO) or pharmaceutical company and/ or 4 years of pharmacovigilance experience or equivalent experience.
• Knowledge of global and local PV regulations and legislation, both pre- and post-marketing, preferred.
• Strong project management, interpersonal, verbal and written communication skills, both internally and towards clients.
• Ability to identity, document, track and resolve project action items for multiple programs simultaneously.
• Ability to create, review and revise documentation, processes and procedures as they relate to PV activities, to identify issues/problem areas, assess compliance, and communicates findings to the appropriate team(s) and management.
• Experience with Argus or other industry standard safety database(s)
• Project financial expertise including invoicing, revenue recognition, margin analysis, scope management and resource management.
• Demonstrated supervisory skills preferred.
• Demonstrated independent problem solving and issue resolution track record.
• Excellent interpersonal and client management skills.
• Must be flexible and adaptable to quickly changing project priorities
• Must be able to speak fluent English.
• Ability to travel to UBC locations, clients, and professional/scientific meetings.

Supervisory Responsibilities :

Matrix supervision of project team(s).

Expected Project Load:

2 to 5 projects (global and local) depending on scope.

Specific Job Duties:

• Manages Pharmacovigilance project(s) as assigned by UBC PV Management per the scope of work and within the contracted budget and timelines.
• Responsible for the overall on time, on-budget delivery of the contracted Scope of Work for assigned projects.
• Oversees all aspects of the PV project conduct from Start-up through Close-Out.
• Responsible for on-time and on-budget delivery of the project
• Serves as UBC primary contact with the client.
• Ensures appropriate project related communication within the project team.
• Leads and coordinates internal project and client teleconferences/meetings.
• Prepares project timelines and project management related deliverables.
• Identity, document, track and resolve project action items for multiple programs simultaneously
• Establishes and manages project communication tools (e.g. project email address, project specific teleconference number, project portal/SharePoint).
• Coordinates development of Project Specific plans to achieve contracted milestones (i.e., Adverse Event Reporting Plan, Periodic Safety reporting Plan).
• Prepares and maintains Project Management Plan.
• Ensures project is conducted in concert with UBC Standard Operating Procedures (SOPs), project-specific procedures and client’s SOPs and, in accordance to the highest quality standards.
• Prepares and keeps the Project team log and project specific training matrix up-to-date.
• Ensures project specific trainings are assigned to relevant project team member as per project specific training matrix.
• Maintains and files project specific training records for the project team.
• Prepares project metrics & Key Performance Indicators (KPI) and monthly metrics reports, as needed.
• Supports Qualified Person Responsible for Pharmacovigilance in Europe (EU QPPV) and local QPPV(s) in his/her activities throughout the project.
• Prepares project specific presentations for client meetings/audits.
• Assists in project specific audit/inspection preparation and actively participate in the audit/inspection.
• Develops and implements Corrective and Preventive Actions (CAPAs) related to Project Management issues as necessary.
• Ensures that project specific CAPAs/SIRs are being closed on time.
• Tracks non-compliance issues occurring in the frame of his/her projects.
• Escalates issues in a timely manner to the PV Director /Associate Director who supervises the project.
• Maintains cumulative list of Actions items for the project including owner, due date, status, etc…
• Reviews contract and project scope to ensure that change orders (CO) are issued as necessary.
• Works with UBC contracts team on CO development and execution.
• Performs project financial oversight (identify percent complete units for monthly revenue recognition meeting with Finance as well as forecast future unit completion).
• Ensure project budget is tracked against contract milestones.
• Oversees project profitability analysis and present findings as requested to Senior PV Management.
• Supports business development initiatives including proposal, slides, attendance at bid defense meetings and proposal and budget development.
• Determines the need for third party vendor services and coordinate vendor management activities
• Other duties as assigned by Senior Management.

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers:

Remote opportunities

Growth opportunities for promotion

401K with company match*

Discretionary PTO (Paid Time Off)

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short-term disability

Long term disability

Life insurance

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.