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PV Officer, Team Lead (Japanese fluency required)

PrimeVigilance -
Sydney NSW

Quick Apply

Job Details

Full-time

Qualifications

English
Japanese
Communication skills
Time management

Full Job Description

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

Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader
Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process
Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management

Role and Responsibilities

Providing support to other activities undertaken by the project team on behalf of the client and the company
Line Manages assigned ICSR staff
Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency)
Proposes process changes to ICSR Operational Lead
Manages ICSR deviations with ICSR Operational Lead support
Reviews trackers and timesheet data and ensures accuracy
Is involved in ICSR processing and 2nd QC of cases
Operates as the assigned team SME and supports other SMEs

Qualifications

Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
Extensive experience in pharmacovigilance within which demonstrated work experience in line manager role.
Excellent communication (written and verbal) skills
Organization skills, including attention to details and multitasking
Delegation skills
Planning and time management
Technical skills
Team working
Fluency in English and Japanese

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.

Quick Apply

Refine Your Search

biotechnology jobs

PV Officer, Team Lead (Japanese fluency required)

Laboratory Assistant

Associate QA Officer

Regulatory Affairs Specialist

Quality Associate Visual Inspection/Pack

Service Support Coordinator

Head of Community & Patient Engagement

Process Engineer (GMP) Brisbane

Commercial Account Executive – Health & Life Sciences (HLS)

Hospital Relationship & Inventory Coordinator (VIC)

Senior Scientist Digital Quality Control

Regulatory Submissions Coordinator

Field Service Coordinator NSW

QC Team Leader - Physiochemistry & Raw Material

Assistant Brand Manager - Aesthetics

Business Development Manager, Integrated Laboratory Workflows

Associate | Intellectual Property

Clinical Support Specialist - Spine

Quality Assurance Engineer

Field Service Engineer – WA/NT

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