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Ergomed PV Officer in Cary, North Carolina

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

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

Line Management tasks (periodic appraisals, performing vacation approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)

Mentoring and training of new and more junior employees within the department

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 Sciences Graduate, pharmacy, nursing, or other healthcare related qualification

2-5 years in Pharmacovigilance

English, Advanced

Why Should You Apply?

  • You want be involved in a wide range of interesting projects and studies

  • You'd like your achievements and hard work to be recognized

  • You want to work for a growing company where there are opportunities for advancement

  • You'd like to work in a company that has a great reputation with its clients and employees.

  • Making a difference to people's lives matters to you