Ergomed

Healthcare

SeniorPharmacovigilanceOfficer,TeamLead/CaseProcessingManager-MedicalDeviceexperienceneeded

€140–210k ~AI est. Bucharest, Bucharest, Romania FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for mid candidates.

The Brief

“Senior Pharmacovigilance Officer, Team Lead/ Case Processing Manager- Medical Device experience needed at Ergomed. Skills: Pharmacovigilance, Case processing, Team leadership. Lead ICSR management team. Line manage ICSR staff”

What You'll Achieve.

Achieve company goals

Industry & Context.

Healthcare

What They're Looking For.

Must Have

Life science graduate, Pharmacy qualification, Nursing qualification, Healthcare related qualification, Pharmacovigilance experience, 1 year line manager experience, Medical Device experience required, Fluent English spoken, Fluent English written, Advanced MS Office literacy

Nice to Have

Experience in pharmacovigilance

What You'll Do.

Lead ICSR management team

Line manage ICSR staff

Ensure task distribution

Oversee workflow process

Cooperate with clients

Contribute to company goals

Work under supervision

Provide project support

Create project specific KPIs

Increase ICSR team efficiency

Propose process changes

Manage ICSR deviations

Review timesheet data

Support other departments

Support RA & PV Network

How You'll Work.

Team & Collaboration

RA & PV Network Department

Communication Scope

Written communication; Verbal communication

Process & Methodology

Planning, Time management

Full Job 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. * Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader and Line Manages ICSR staff * 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 * Contributes to achieving company´s goals and objectives * Works under supervision of ICSR Operational Lead * ​​Role and Responsibilities​ * Providing support to other activities undertaken by the project team on behalf of the client and the company * 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 a

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