Senior PV Associate
Ergomed
Summary
Providing support to other activities undertaken by the project team on behalf of the client and the company.
Job description
Job Description
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 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.
Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager.
Requirements
- Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
- Minimum 1 year of work experience in pharmacovigilance
- Organization skills, including attention to detail and multitasking
- Management skills, including time and issue management
- English - advanced (spoken, written)
- Advanced literacy (MS Office)
Benefits
- Training & Career Development
- Personal & Professional Growth
- Supportive Working Environment
- Global Collaboration
Company overview
Ergomed is a global clinical research organization (CRO) that provides comprehensive drug development services to pharmaceutical and biotechnology companies worldwide. Founded in 1997, the company specializes in managing clinical trials across all phases, from early-stage development through post-marketing studies. Ergomed offers a full spectrum of services including clinical trial management, regulatory affairs, pharmacovigilance, medical writing, and quality assurance. The organization has established a strong reputation for its therapeutic expertise in areas such as oncology, rare diseases, and central nervous system disorders. With operations spanning multiple countries, Ergomed supports clients in navigating complex regulatory environments and accelerating the development of innovative therapies. The company's integrated approach combines scientific excellence with operational efficiency to deliver high-quality clinical research services that help bring new treatments to patients faster.