Pharmacovigilance Project Manager (Japanese fluency required)

Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

Acting as the primary contact point for project-related matters

Managing client’s expectations to make sure the client is satisfied with services of PrimeVigilance, and that the work PrimeVigilance delivers meets, or even exceeds, the clients’ expectations.

Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance.

Project activities planning, including deadlines and interim milestones

Reporting for the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing.

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

English and Japanese language fluency skills

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.