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Ergomed PV Associate in Cary, North Carolina

Assures and exerts 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 more experienced colleague

Providing support to other activities undertaken by the project team on behalf of the client and the company

Interested in pursuing a career in pharmacovigilance

Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):

· Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines

· Performing ICSR follow up

· SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)

· Reconciliation (clinical, partners)

· Personal data protection

· Product Quality Complaint handling and interaction with Quality Assurance

· Medical Information interaction

· MedDRA and WHO coding

· Database Outputs and Reports (including data for monthly reporting to clients)

· Workflow & resource management

Support of PV processes related to the ICSR management within PrimeVigilance and also to clients

More senior colleague may perform tasks assigned as per SOP to more junior position

Performing activities in the scope of ICSR management unit within agreed extent and timeframe.

Life science graduate, pharmacy, nursing or other healthcare related qualification

Organization skills, including attention to detail and multitasking

Management skills, including time and issue management

All your information will be kept confidential according to EEO guidelines.

Our Offer:

  • Work within a successful, highly – qualified and dynamic team

  • Professional training and career development in a fast-growing healthcare company