PrincipalSenior Pharmacovigilance Project Manager

Prague - Czech Republic

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Department:

Project Management

Job Summary

Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget and are on time with good quality and in compliance with the applicable regulatory requirements.
Providing support to Director of Projects and senior leadership management as applicable inother activities undertaken on behalf of the client and the company.
Acting as the primary contact point for project-related matters
Workflow management KPI/metric reporting
Manage changes to the project scope project schedule and project costs as applicable
Maintaining good client relations and ensuring a consistently high quality of work for each client
Understand client PV requirements and ensure service provided addresses all requirements
Project set-up and maintenance activities planning; Organising/chairing and attending regular client meetings
Having an overview of all tasks to be delivered to the client including deadlines and interim milestones
Assurance of training of all team members from relevant quality documents including project-specific documentation
Close cooperation with other Primevigilance and/or the clients respective departments making sure contracted activities are delivered with high quality and within set timelines
Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
Preparation of client specific core documents (e.g. Join operational guidelines Safety management plan Monthly reports etc) as applicable
Preparation of invoices project financial analysis
Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
Managing Quality Management System activities for the client; development of standard operating procedures and operational guidelines maintaining compliance with the PV system and providing PV training as required

Qualifications :

Proven track record of demonstrated Pharmacovigilance activities including processing and quality review of ICSRs writing or contributing to aggregate reports literature screening reconciliation and preparation of SOPs
PV Project Management experience from ideally a service provide / CRO
Health Care Professional or Life Science Graduate
Be comfortable with communicating at senior levels within pharmaceutical organizations
Have good leadership qualities including skills in planning mentoring meeting facilitation communication and problem solving.

Additional Information :

Why PrimeVigilance

We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

Training and career development opportunities internally
Strong emphasis on personal and professional growth

Friendly supportive working environment
Opportunity to work with colleagues based all over the world with English as the company language

Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!

Quality

Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships

We look forward to welcoming your application.

Remote Work :

Yes

Employment Type :

Full-time

Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget and are on time with good quality and in compliance with the applicable regulatory requirements.Providing support to Director of Projects and senior leadership management as applicable i...

Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget and are on time with good quality and in compliance with the applicable regulatory requirements.
Providing support to Director of Projects and senior leadership management as applicable inother activities undertaken on behalf of the client and the company.
Acting as the primary contact point for project-related matters
Workflow management KPI/metric reporting
Manage changes to the project scope project schedule and project costs as applicable
Maintaining good client relations and ensuring a consistently high quality of work for each client
Understand client PV requirements and ensure service provided addresses all requirements
Project set-up and maintenance activities planning; Organising/chairing and attending regular client meetings
Having an overview of all tasks to be delivered to the client including deadlines and interim milestones
Assurance of training of all team members from relevant quality documents including project-specific documentation
Close cooperation with other Primevigilance and/or the clients respective departments making sure contracted activities are delivered with high quality and within set timelines
Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
Preparation of client specific core documents (e.g. Join operational guidelines Safety management plan Monthly reports etc) as applicable
Preparation of invoices project financial analysis
Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
Managing Quality Management System activities for the client; development of standard operating procedures and operational guidelines maintaining compliance with the PV system and providing PV training as required

Qualifications :

Proven track record of demonstrated Pharmacovigilance activities including processing and quality review of ICSRs writing or contributing to aggregate reports literature screening reconciliation and preparation of SOPs
PV Project Management experience from ideally a service provide / CRO
Health Care Professional or Life Science Graduate
Be comfortable with communicating at senior levels within pharmaceutical organizations
Have good leadership qualities including skills in planning mentoring meeting facilitation communication and problem solving.

Additional Information :

Why PrimeVigilance

To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

Training and career development opportunities internally
Strong emphasis on personal and professional growth

Friendly supportive working environment
Opportunity to work with colleagues based all over the world with English as the company language

Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!

Quality

Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships

We look forward to welcoming your application.

Remote Work :

Yes

Employment Type :

Full-time

Key Skills

Business Development
Project Management Methodology
Project / Program Management
PMBOK
Waterfall
Wastewater
Construction Management
Project Management
Project Management Software
Microsoft Project
Budgeting
Contracts

Apply Now

About Company

Ergomed

Ergomeds fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. ... View more

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