Global Provider of Expert, High-Quality Services to the Biopharmaceutical Industry. Your Full-Service Solutions Partner.
Senior PV Associate
Location
Romania
Posted
5 hours ago
Salary
0
Seniority
Senior
Job Description
Senior PV Associate
ERGOMED
• 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 • 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 • 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
Job 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 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
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